Oral berberine alone or combined with letrozole × Cumulative live birth in infertility associated with PCOS

Required evidence, verification status and materials actually read
Item	AVerification status	BReading scope	CReview item	DCurrent findings	EWhy unverified	FRequired materials and conditions	GFurther research
1	Met	Full text not readStored summary read	N01 · Evidence conditionIs the question fixed to cumulative live birth with berberine alone versus letrozole alone?Required	The original claim concerns cumulative live birth in infertile women with PCOS. This sheet concerns berberine alone versus letrozole alone; the original detailed-claim list is empty. S01	The original claim and derived-comparison boundary match the current input and formal assignment. The derived ID was not turned into an index in the original detailed-claim list.	Linked records of the original claim, intervention, comparator and derived-comparison boundary	If the boundary changes, redefine the actual intervention/comparator combination and review it in a separate version.
2	Met	Full text not readStored summary read	N02 · Evidence conditionAre the two monotherapy arms and the roles of double-dummy placebos distinguished in the retained account?Required	The retained account describes double-dummy berberine/placebo and letrozole/placebo and a 3-arm RCT. The selected comparison is berberine alone versus letrozole alone. S01	The selected arms’ roles can be distinguished in the current description. Actual success of blinding has not been established.	Records of active ingredients, placebo allocation and actual comparator roles in the 3 arms	If the full protocol is obtained, compare active/placebo allocation by arm and keep different strategies distinct.
3	Unverified	Full text not readStored summary read	N03 · Evidence conditionAre the trial berberine’s exact salt form, source, product and standardization established?Required	The original claim conditions leave the exact salt form and plant source unverified. The retained account also keeps berberine hydrochloride, plant extracts, combination formulas and other derivatives distinct. S01	The exact product form and standardization cannot be established from the retained material.	Berberine product name, manufacturer, salt form, batch and standardization material	If original product material is obtained, compare composition and standardization and review unmatched products as separate questions.
4	Partly verified	Full text not readStored summary read	N04 · Evidence conditionAre the planned oral berberine monotherapy dose, actual intake and adherence established?Required	The oral route and planned berberine 1.5 g/day are specified. Actual intake, adherence and discontinuation details are absent from current material. S01	The planned oral dose is established, while actual individual exposure is not.	Arm-specific prescriptions, adherence, actual daily doses and discontinuation records	Use dosing records to distinguish planned from actual exposure and compare the effects of deviations with the predefined analysis.
5	Partly verified	Full text not readStored summary read	N05 · Evidence conditionAre the active letrozole comparator’s planned dosing, escalation and actual administration established?Required	The plan of 2.5 mg on cycle days 3–7, increasing to 5 mg if needed, is retained. Actual escalation, cycle counts and adherence by arm are unverified. S01	The comparator drug’s plan is established, but actual administration records are unverified.	Comparator-arm letrozole prescriptions by cycle, dose escalation and actual intake records	Compare actual comparator dosing by cycle with the planned escalation criteria.
6	Partly verified	Full text not readStored summary read	N06 · Evidence conditionAre the actual population and Rotterdam PCOS/infertility eligibility criteria sufficiently established for the selected comparison?Required	The recruited population is described as 644 infertile women meeting Rotterdam PCOS criteria. Detailed diagnosis, age, infertility duration and exclusions are absent from current material. S01	The principal population category is established, while detailed eligibility and arm-specific characteristics remain unverified.	Diagnosis, age, infertility duration, inclusion/exclusion criteria and arm-specific population characteristics	If eligibility criteria and baseline tables are obtained, compare the target population with the actual trial population.
7	Unverified	Full text not readStored summary read	N07 · Evidence conditionAre baseline infertility causes, prior treatment and arm-specific prognostic characteristics established?Required	Current material describes infertile women with Rotterdam PCOS but provides no tables of baseline causes, previous treatment or arm-specific characteristics. S01	Material needed to establish baseline prognostic balance in the selected arms is absent.	Arm-specific baseline tables, investigations of infertility causes, prior treatment and medical histories	Compare baseline material with planned handling of prognostic variables and actual balance.
8	Partly verified	Full text not readStored summary read	N08 · Evidence conditionAre actual random-sequence generation and implementation of the allocation ratio established in this multicenter trial?Required	A multicenter double-blind 3-arm RCT with 644 participants and 1:1:1 allocation is described. Sequence generation, stratification and site-specific implementation remain unverified. S01	The design and allocation ratio are described, but actual randomization procedures are not established.	Random-sequence generation, stratification, site-specific allocation procedures and CONSORT flow material	Compare the protocol and allocation procedures to examine implementation of randomization for the selected arms.
9	Unverified	Full text not readStored summary read	N09 · Evidence conditionAre allocation concealment and recruitment procedures established for the two selected arms?Required	The current summary describes an RCT but lacks details of allocation concealment, enrollment sequence and recruitment implementation. S01	The label randomized trial cannot substitute for actual implementation of allocation concealment.	Allocation concealment, enrollment timing, recruitment sequence and actual implementation material	Obtain allocation/enrollment documents to examine concealment procedures in relation to recruitment timing.
10	Partly verified	Full text not readStored summary read	N10 · Evidence conditionAre actual double-dummy blinding and the independence of live-birth ascertainment established?Required	Multicenter double blinding and a double dummy are described. Placebo appearance, actual maintenance of blinding and the persons/procedures confirming births remain unverified. S01	The planned design is described, but actual blinding and ascertainment implementation are not established.	Placebo matching, maintenance/breaking of blinding, outcome assessors and verification procedures	Compare protocol and ascertainment documents to examine implementation of blinding and independence of outcome assessment.
11	Unverified	Full text not readStored summary read	N11 · Evidence conditionAre concomitant/rescue treatments and deviations established in the two monotherapy-strategy arms?Required	The current summary gives only selected-arm names and planned doses; actual concomitant/rescue treatment, crossover and reasons for discontinuation are absent. S01	Material needed to establish differences in other treatments within the selected comparison is absent.	Arm-specific concomitant/rescue treatment, crossover, other infertility treatment and reasons for discontinuation	Reconstruct arm-specific treatment pathways to examine the definition of the effect of interest and appropriate handling of deviations.
12	Partly verified	Full text not readStored summary read	N12 · Evidence conditionAre the maximum 6-month plan, actual individual treatment/cycle counts and exposure after pregnancy established?Required	A maximum 6 months and pregnancy-outcome follow-up are described as a plan. Actual individual administration, cycle counts, discontinuation and exposure after pregnancy remain unverified. S01	The duration plan is established, but actual exposure length and discontinuation pathways are not.	Arm-specific actual treatment duration, cycle counts, discontinuation timing and dosing after pregnancy	Distinguish the treatment calendar from pregnancy follow-up and examine actual exposure duration and discontinuation pathways.
13	Unverified	Full text not readStored summary read	N13 · Evidence conditionAre the length, end and completeness of pregnancy follow-up for live-birth ascertainment established?Required	The original claim conditions state a maximum 6 months with pregnancy-outcome follow-up, but length through birth, arm-specific follow-up end and completeness are absent. S01	The exact observation window used to establish birth outcomes cannot be determined from current material.	Arm-specific pregnancy/birth follow-up schedules, last contact, follow-up end and completeness	Compare the observation window from pregnancy onset to birth confirmation with incomplete follow-up.
14	Partly verified	Full text not readStored summary read	N14 · Evidence conditionAre the event definition, cumulative method and measurement unit of cumulative live birth sufficiently established?Required	Cumulative live birth during treatment is specified as the principal endpoint. Gestational-age criteria, woman/infant units, multiple births and cumulative counting rules remain unverified. S01	The principal endpoint label is established, but actual event definition and unit are not sufficiently established.	Endpoint definition, birth-verification procedures, cycle-accumulation rules and handling of multiple/repeated births	Obtain endpoint specifications to examine consistency of woman, cycle and infant units with cumulative counting.
15	Met	Full text not readStored summary read	N15 · Evidence conditionAre the original reported rates of 22% versus 36% accurately attributed to the monotherapy comparison?Required	The original results are letrozole 36%, combination 34% and berberine 22%. The selected monotherapy comparison is berberine 22% versus letrozole 36%; no new difference or statistic was calculated. S01	The narrow attribution of arm names and reported rates matches the retained account. This does not establish formal between-arm effects or precision.	Attribution records linking each arm’s reported rate, name, original statement and result location	When new reports are obtained, first verify arm names for the same endpoint, denominator and time, then compare with existing attribution.
16	Unverified	Full text not readStored summary read	N16 · Evidence conditionAre randomized, analyzed, completed and endpoint-observed denominators established for the two selected arms?Required	Only 644 participants overall and 1:1:1 allocation are described. Arm-specific randomized, analyzed, completed and birth-observed denominators are absent. S01	The overall count and allocation ratio do not establish actual integer denominators for each arm.	CONSORT counts, analysis populations, birth-endpoint denominators and missing-data flow for the two selected arms	Compare definitions of each denominator to distinguish overall allocation from the endpoint-analysis population.
17	Unverified	Full text not readStored summary read	N17 · Evidence conditionAre live-birth event counts and person/infant/cycle units established for the two selected arms?Required	The original results contain only three-arm percentages; original live-birth events, denominators and repeated/multiple-birth handling are absent. S01	Percentages alone cannot establish actual event counts or units.	Original live-birth events, denominators, units and handling of repeated/multiple births	Obtain original result tables to examine the relation between events and person/cycle denominators.
18	Unverified	Full text not readStored summary read	N18 · Evidence conditionAre the effect of interest, ITT/PP and handling of intercurrent events established for the monotherapy-strategy comparison?Required	The current summary gives only the principal endpoint and arm-level reported rates; estimand, ITT/PP and specifications for intercurrent events or missing data are absent. S01	The effect of interest and actual analysis population for the selected comparison have not been established.	Estimand specifications, ITT/PP populations and plans/results for intercurrent events and missing data	After establishing the estimand and analysis populations, examine how pregnancy, discontinuation and rescue treatment enter the definition.
19	Unverified	Full text not readStored summary read	N19 · Evidence conditionAre the formal estimator, method, P and confidence interval for the selected between-arm effect established?Required	Current material contains only arm-specific percentages; the formal effect estimator, model, P and confidence interval for the selected comparison are absent. S01	Reported rates are established, but material needed to establish formal comparison estimates and confidence intervals is absent.	Original between-arm effect estimates, model, P, confidence interval, denominator and endpoint time	Compare original analysis tables and the SAP to establish comparison estimates and precision. Do not exclude an unadjusted analysis solely because it is unadjusted.
20	Unverified	Full text not readStored summary read	N20 · Evidence conditionAre clinical importance and interpretation criteria for superiority, noninferiority or equivalence established for the selected comparison?Required	The retained account describes a lower live-birth direction with monotherapy. Importance criteria, superiority/noninferiority/equivalence hypotheses and confidence intervals remain unverified. S01	The original conclusion’s direction alone cannot newly establish clinical importance, equivalence or 0 effect.	Hypotheses, clinical-importance/noninferiority margins, effect confidence intervals and interpretation plans	Establish original hypotheses and margins, then examine how confidence intervals address clinically important differences.
21	Unverified	Full text not readStored summary read	N21 · Evidence conditionAre losses, missing data, incomplete birth follow-up and the effects of their handling established for the selected arms?Required	The current summary lacks counts of losses, missing data and incomplete birth follow-up, their handling and sensitivity results. S01	Material needed to establish how missing-data handling affects reported arm-level rates is absent.	Arm-specific losses, missing/incomplete pregnancy or birth follow-up, reasons, handling and sensitivity material	Examine consistency between missing-data flow and planned handling and establish the scope of original sensitivity analyses.
22	Unverified	Full text not readStored summary read	N22 · Evidence conditionIs consistency of preregistration, protocol and SAP with actual reporting established for the selected comparison?Required	ChiCTR-TRC-09000376 and a historical statement matching the paper with WHO/ChiCTR are retained. Actual registration versions, SAP and change history have not currently been acquired or read. S01	The identifier and historical matching statement alone do not establish consistency between actual prior plans and reporting.	Actual ChiCTR/WHO registration versions, change histories, protocol, SAP and original result tables	If registration and SAP are obtained, compare registration timing, hypotheses, arms, endpoints and analyses with reporting.
23	Unverified	Full text not readStored summary read	N23 · Evidence conditionAre multiplicity handling and hypothesis hierarchy established for the two derived comparisons in the 3-arm trial?Required	The original material describes a 3-arm RCT but lacks the two comparisons’ prespecified hierarchy, multiplicity handling and selection from all results. S01	Producing two sheets does not establish the trial’s hypotheses or handling of multiplicity.	3-arm hypothesis hierarchy, multiplicity handling, comparison-specific SAP and reported results	Compare the original SAP with complete results to examine comparison selection and multiplicity handling.
24	Met	Full text not readStored summary read	N24 · Evidence conditionAre both the unfavorable monotherapy direction and the historical no-added-benefit statement retained?Required	The original three-arm rates, statements that monotherapy was lower and addition did not increase live birth, the separate metabolic counterview, D 34 and all axes are retained. S01	The current input’s unfavorable direction, counterview and assessment were not deleted or recalculated. This is not new certification of clinical effects.	Preservation records of original results, counterviews, original assessment, axes and correction history	If subsequent reports become available, compare favorable, unfavorable and no-benefit material under the same attribution rules and record changes as separate events.
25	Met	Full text not readStored summary read	N25 · Evidence conditionAre the ChiCTR link, exclusion of the wrong NCT and original unverified registration-field wording kept distinct?Required	The bibliography lists PMID 27336209, DOI 10.1016/j.fertnstert.2016.05.022 and ChiCTR-TRC-09000376. The original central point excludes NCT01116167, while the evidence-table registration field remains “not established.” S01	The established historical identifier link and the original field’s unverified label are retained separately. Current external registration verification is not complete.	Linked records of PMID, DOI, ChiCTR, excluded NCT and the original registration field	If actual registration material is obtained, compare identifiers, population, 3 arms and endpoints and record discrepancies as separate correction events.
26	Met	Full text not readStored summary read	N26 · Evidence conditionIs it explicit that the two derived sheets concern the same 3-arm trial and shared letrozole arm?Required	The retained original set contains 1 3-arm RCT report. Both sheets share the same 644-participant trial and letrozole control and are not counted as independent repeated trials or two participant populations. S01	The two comparisons and shared-control relationship within the same report are explicit.	Relationship records linking one study family, two comparisons, the shared control and report identifiers	Compare report populations, recruitment and identifiers to link the same family and duplicated controls.
27	Unverified	Full text not readStored summary read	N27 · Evidence conditionAre independent replication of the same question and the scope of access established?Required	The current retained set contains 1 direct 3-arm trial report, and no new clinical search was performed. Material establishing independent replication is absent. S01	Having one retained report does not prove that only one human study, or no human studies, exist worldwide.	Identities, reports, search scope and original material for independently recruited studies	If new-material review is authorized, assess question-specific eligibility and compare independent recruitment and report overlap.
28	Not applicable	Full text not readStored summary read	N28 · Evidence conditionIs there an applicable set for examining heterogeneity between distinct independent trials in the current retained material?Supplementary; required when synthesizing multiple independent study families	The current retained report set contains only 1 direct 3-arm trial, and the two derived sheets belong to the same family. Multiple families needed for between-independent-trial heterogeneity are absent from this set. S01	There is no narrow applicable set for between-independent-trial heterogeneity in the current retained material. Unverified replication, denominators or precision are not changed to not applicable.	Differences in populations, interventions, endpoints and analyses if additional independent families are established	If a separate family is obtained, compare question matching and design, population and estimator differences to examine whether synthesis is appropriate.
29	Unverified	Full text not readStored summary read	N29 · Evidence conditionAre monotherapy dose response, longer-term effects and subgroup effects beyond the trial dose/duration established?Supplementary; required when extending to other doses, durations or subgroups	Current material describes berberine 1.5 g/day, a maximum 6-month plan and results in specific infertile women with PCOS. Direct material for other doses, longer durations and subgroups is absent. S01	Current material does not establish extended effects. This gap differs from the formal effect of the narrow selected comparison.	Direct comparisons and interaction data for additional doses, durations, products and subgroups	When an extension question is needed, review its material as a separate question; do not read simple subgroup differences as interactions.
30	Met	Full text not readStored summary read	N30 · Evidence conditionIs the boundary between live birth and ovulation, pregnancy, metabolic or weight outcomes maintained?Required	The original explanation and summary state that only live birth is assessed and that ovulation, pregnancy rates, insulin and weight are separate. This sheet maintains that boundary. S01	The narrow record condition of keeping the principal birth endpoint distinct from other intermediate outcomes is established.	Records of endpoint hierarchy and attribution boundaries for other outcomes	If material on other outcomes is obtained, review those questions separately and interpret their relationship to live birth only where direct linking evidence exists.
31	Partly verified	Full text not readStored summary read	N31 · Evidence conditionAre funding, product support, author relationships and conflicts specifically established?Required	The original funding field says “public research network; details of product support to be checked.” Exact institutions, product providers, author relationships and conflict details are absent from current material. S01	The support category is described, while product-support and conflict details are not established. Generic English wording does not replace actual declaration content.	Funding bodies, research funding, berberine/letrozole supply, author relationships and conflict declarations	Compare original support and conflict statements to establish research funding, product provision and author relationships separately.
32	Unverified	Full text not readStored summary read	N32 · Evidence conditionAre actual maternal, pregnancy and fetal/neonatal harm collection and results established for the selected comparison?Supplementary; required when explaining pregnancy safety or personal-use decisions	The retained account contains warnings about trying to conceive and fetal/neonatal bilirubin. Actual harm events, person denominators, timing, collection, discontinuation and comparative risks for the selected arms are absent. S01	Warning statements do not replace confirmation of actual trial harm collection and incidence.	Arm-specific maternal/pregnancy/fetal/neonatal harm definitions, active collection, event/person denominators, timing, exposure, discontinuation and concomitant-treatment material	If original safety material is obtained, compare harm definitions, collection, follow-up, denominators and discontinuation/concomitant treatment to distinguish signals from comparative risks.
33	Met	Full text not readStored summary read	N33 · Evidence conditionAre historical warnings, actual trial harms and personal-use decisions kept distinct?Required	The original safety warning and advice to consult a clinician are retained as historical text. This sheet does not turn them into new incidence estimates, established causation, safety at every dose or personal dosing instructions. S01	The narrow record condition distinguishing historical warnings from this sheet’s material-verification scope is established.	Records distinguishing the roles of original safety warnings and actual event material	If original safety material is added, establish the warning’s basis, population and events and examine these separately from comparative risk.
34	Met	Full text not readStored summary read	N34 · Evidence conditionAre the original review date, correction date, current sheet-review date and search/reading limits distinguished?Required	The original verdict review date is 2026-09-08 and the correction date is 2026-09-14. This sheet’s record-review date is 2026-10-05; no new clinical search or external reading was performed. Original search-cutoff and report-specific access-date fields are absent. S01	Different dates and the actual current reading scope are recorded separately. This does not establish a completed comprehensive current search.	Original review date, correction date, current review date, search scope and actual access records	When new evidence updating is authorized, record search dates, scope and access events as new records without backdating historical dates.
35	Met	Full text not readStored summary read	N35 · Evidence conditionAre English correction history, remaining generic wording and original null/empty values retained?Required	The record describes a 2026-09-14 correction of 1 generic English field while retaining grade, score and date. Remaining generic sample-size, funding and result English wording, empty detailed-claim lists/review notes and the complete original material are retained. S01	Specific translations remain distinguished from generic verification wording, without generating absent numbers, confidence intervals or funding declarations.	Preservation records of original corrections, bilingual fields, empty values, absent fields and types	If a new bilingual correction is needed, establish corresponding original values and the correction event and preserve the entire text before change.
36	Met	Full text not readStored summary read	N36 · Evidence conditionAre current retained-summary reading, unread external materials and historical matching statements separated by material type?Required	The complete bilingual account, evidence, bibliography and corrections in the current input were read. The original research-review statement about matching the paper with WHO/ChiCTR is historical; all current external access and reading remain unattempted. Individual access dates/levels are null because the original fields are absent. S01	Actual current local reading, unread external materials and historical statements are separated by physical material type.	Material-specific current acquisition/reading, URL, version, historical access date/level and original-location records	If external material is actually obtained, verify its own access event, version and original locations and update only the current reading record.

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36 itemsWhat the statuses mean

Assessment scope

Stored-material review date: 2026-10-05
Original evidence review date: 2026-09-08
Scope actually checked: Retained Korean/English summaries and case-specific condition/application records. Full papers, supplements, registrations, plans and original data were not read.
What the dates mean: The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Population: The trial recruited 644 infertile women meeting Rotterdam PCOS criteria. The 644 describes the overall recruited population, not the analysis denominators of the selected two arms. Detailed diagnosis, age, infertility duration, other infertility causes, baseline prognosis and eligibility remain unverified.
Ingredient, formulation and route: The selected intervention is an oral berberine monotherapy strategy. Double-dummy tablets are described, but exact salt form, plant source, product, standardization and batch remain unverified. The combination arm provides context from the same trial and is not inherited as an observation of this monotherapy comparison.
Dose: The planned berberine dose was 1.5 g/day. Comparator letrozole was planned at 2.5 mg on cycle days 3–7, increasing to 5 mg if needed. Actual administration, dose escalation, adherence, discontinuation and exposure after pregnancy remain unverified. This is not an instruction for personal use.
Comparator: The comparator is an active letrozole monotherapy strategy. The overall study is described as a 3-arm double-blind, double-dummy randomized trial. Double-dummy placebos are not reinterpreted as a pure no-treatment control. The two derived comparisons share the letrozole arm.
Measured outcome: The endpoint is cumulative live birth during treatment. Retained reported rates are 36% with letrozole, 34% with the combination and 22% with berberine alone; the selected comparison is berberine 22% versus letrozole 36%. Event definition, arm-specific denominators/events and formal between-arm estimates/P/CI remain unverified. The original D grade, 34 points and Warning are retained as historical records, not a new assessment.
Duration: Up to 6 months of treatment and pregnancy-outcome follow-up are described. Individual actual exposure, cycle counts, discontinuation and the length, end and completeness of follow-up through birth remain unverified. The maximum 6 months is not treated as every woman’s actual treatment duration or the end of birth follow-up.
Questions outside this scope: Ovulation, pregnancy rates, insulin and weight outcomes do not replace a live-birth effect.; Salt forms, plant extracts, combination products, dihydroberberine, other derivatives and topical products are not interchangeable.; Do not generate arm denominators from 644/3 or back-calculate events from percentages. No new differences, RR, OR, NNT, CI or P are calculated.; The same 3-arm trial and shared letrozole arm are not added as independent trials or independent participant populations.; Retain the lower reported direction in the monotherapy arm without converting it into 0 effect, equivalence, noninferiority or formal between-arm precision.; Retain the original pregnancy and fetal/neonatal bilirubin warning. Actual harm incidence, causation, post-pregnancy exposure and long-term safety remain unverified; no new personal dosing instruction is created.; Distinguish ChiCTR-TRC-09000376 from the excluded NCT01116167 and retain the unverified entry in the original registration field.; Reading retained summaries is not represented as current reading of external abstracts, full texts, registration, protocols or analysis plans.

Evidence and sources

The links below lead to the sources. A link alone does not mean the original source was read or its latest publication status verified.

S01 · Wu 2016 PCOS double-dummy 3-arm cumulative live-birth report

PubMed

Material type: Retained bibliographic and result summary of the same 3-arm randomized trial. The selected question is monotherapy versus active letrozole.
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Findings recorded in the stored summary: Described as a multicenter double-blind 3-arm trial with 644 participants overall and 1:1:1 allocation. Reported cumulative live-birth rates are 36% with letrozole, 34% with the combination and 22% with berberine. This sheet concerns monotherapy: berberine 22% versus letrozole 36%. The lower monotherapy direction is retained, while arm-specific n/events, formal effects/P/CI, pregnancy follow-up length, product support and actual harms remain unverified. The original planned berberine 1.5 g/day, letrozole 2.5 mg on cycle days 3–7 increasing to 5 mg if needed, and maximum 6 months are not converted into actual individual exposure or the end of birth follow-up.
Record level: Arm-level reported rates and the historical direction of conclusions in the retained summary. The paper, registration and analysis plan are currently unread; no separate effect calculation or reassessment was performed.
Study overlap and independent replication: The retained set contains 1 3-arm report linked to PMID 27336209, DOI 10.1016/j.fertnstert.2016.05.022 and ChiCTR-TRC-09000376. The two derived comparisons share the same study family and letrozole arm. Comparison-specific analysis denominators, covariance and unique participant totals remain unverified. This does not establish independent replication or a new sum of participants.

Public availability, access and reading status by material
Material	Public availability	Access status	Actually read	Notes
Retained Korean/English bibliographic and research summary	Retained copy acquired; summary read	Retained copy acquired; summary read	Stored existing review summary read	The currently retained summary was read. It is distinguished from the paper’s full text. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
PubMed bibliographic/abstract entry	External access not attempted; not acquired; unread	External access not attempted; not acquired	Not read	Only a bibliographic entry is linked; current availability, abstract version and text were not checked. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
DOI/publisher entry	External access not attempted; not acquired; unread	External access not attempted; not acquired	Not read	This DOI entry comes from retained bibliography. The current publisher page, full-text availability and version were not checked. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Original paper full text	External access not attempted; not acquired; unread	External access not attempted; not acquired	Not read	The physical full text’s direct URL, version and retained original remain unverified. A bibliographic link does not mean the full text was read. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Original WHO/ChiCTR registration material	External access not attempted; not acquired; unread	External access not attempted; not acquired	Not read	Only the identifier and historical matching statement are retained. The actual registration version, timing and change history remain currently unverified. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.
Original protocol, analysis plan and supplementary material	External access not attempted; not acquired; unread	External access not attempted; not acquired	Not read	Identity, existence, direct URLs and versions of the protocol, analysis plan and supplementary material remain unverified. Retained bilingual bibliographic and result summaries were read. Historical statements about matching the paper with WHO/ChiCTR are not inherited as current full-text or registration reading. The original review date is 2026-09-08, the historical correction date is 2026-09-14 and the case-record review date is 2026-10-05. Historical access level and access date for individual external materials are not recorded; current access was not attempted.

Report counts versus independent study counts

The retained set contains 1 3-arm report linked to PMID 27336209, DOI 10.1016/j.fertnstert.2016.05.022 and ChiCTR-TRC-09000376. The two derived comparisons share the same study family and letrozole arm. Comparison-specific analysis denominators, covariance and unique participant totals remain unverified. This does not establish independent replication or a new sum of participants.

Review criteria

Version 1.0 · Criteria record date 2026-10-05. These are Chamgap's own application conditions, informed by the referenced methods. They do not constitute official assessment-tool certification or a new efficacy score.

N01 · Is the question fixed to cumulative live birth with berberine alone versus letrozole alone?

Required materials and conditions: Linked records of the original claim, intervention, comparator and derived-comparison boundary
Conditions for verification: Retain the original claim and explicitly identify berberine alone versus letrozole alone as a derived comparison.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Separating a treatment-replacement question from an add-on question prevents monotherapy results from being read as combination effects.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N02 · Are the two monotherapy arms and the roles of double-dummy placebos distinguished in the retained account?

Required materials and conditions: Records of active ingredients, placebo allocation and actual comparator roles in the 3 arms
Conditions for verification: Select berberine alone and letrozole alone; do not read the double dummy as a pure no-treatment placebo arm.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Changing the active letrozole comparator into a no-treatment comparator changes the meaning of the replacement strategy.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N03 · Are the trial berberine’s exact salt form, source, product and standardization established?

Required materials and conditions: Berberine product name, manufacturer, salt form, batch and standardization material
Conditions for verification: Establish the exact chemical form, product identifier, source, content standardization and application to the selected arm.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Product matching prevents monotherapy replacement results from being transferred to arbitrary berberine hydrochloride or plant products.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N04 · Are the planned oral berberine monotherapy dose, actual intake and adherence established?

Required materials and conditions: Arm-specific prescriptions, adherence, actual daily doses and discontinuation records
Conditions for verification: Distinguish planned oral 1.5 g/day from actual intake, adherence, discontinuation and changes.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: It is necessary to know whether actual exposure under the monotherapy strategy matched the planned dose.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N05 · Are the active letrozole comparator’s planned dosing, escalation and actual administration established?

Required materials and conditions: Comparator-arm letrozole prescriptions by cycle, dose escalation and actual intake records
Conditions for verification: Establish planned comparator letrozole 2.5 mg on cycle days 3–7, increasing to 5 mg if needed, alongside actual escalation and administration.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Unclear actual exposure to the active replacement comparator limits interpretation of the monotherapy-strategy comparison.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N06 · Are the actual population and Rotterdam PCOS/infertility eligibility criteria sufficiently established for the selected comparison?

Required materials and conditions: Diagnosis, age, infertility duration, inclusion/exclusion criteria and arm-specific population characteristics
Conditions for verification: Establish the description of infertile women with Rotterdam PCOS and the detailed diagnostic, age and eligibility criteria.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Population conditions prevent extension of this monotherapy comparison to other infertility causes or women generally.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N07 · Are baseline infertility causes, prior treatment and arm-specific prognostic characteristics established?

Required materials and conditions: Arm-specific baseline tables, investigations of infertility causes, prior treatment and medical histories
Conditions for verification: Establish prognosis in the selected arms, including male/tubal factors, baseline ovulatory/metabolic status and previous treatment.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Actual data are needed to examine baseline prognostic balance when comparing the monotherapy replacement strategies.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N08 · Are actual random-sequence generation and implementation of the allocation ratio established in this multicenter trial?

Required materials and conditions: Random-sequence generation, stratification, site-specific allocation procedures and CONSORT flow material
Conditions for verification: Establish not only the multicenter RCT and 1:1:1 description but also sequence generation, stratification and site-specific implementation.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: More than the allocation description is needed to assess selection bias in the two monotherapy arms.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N09 · Are allocation concealment and recruitment procedures established for the two selected arms?

Required materials and conditions: Allocation concealment, enrollment timing, recruitment sequence and actual implementation material
Conditions for verification: Establish recruitment before allocation disclosure, concealment methods and actual implementation in the selected arms.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Recruitment bias from predictable allocation also needs examination in an active-treatment replacement comparison.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N10 · Are actual double-dummy blinding and the independence of live-birth ascertainment established?

Required materials and conditions: Placebo matching, maintenance/breaking of blinding, outcome assessors and verification procedures
Conditions for verification: Establish the double-blind/double-dummy description, placebo matching, unblinding or guessability and birth-ascertainment procedures.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: These conditions examine dosing, subsequent treatment and ascertainment deviations in the comparison of two different active drugs.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N11 · Are concomitant/rescue treatments and deviations established in the two monotherapy-strategy arms?

Required materials and conditions: Arm-specific concomitant/rescue treatment, crossover, other infertility treatment and reasons for discontinuation
Conditions for verification: Establish actual concomitant/rescue and other infertility treatments and differences between the two monotherapy arms.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Different subsequent treatments can prevent attribution solely to replacement with the monotherapy drug.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N12 · Are the maximum 6-month plan, actual individual treatment/cycle counts and exposure after pregnancy established?

Required materials and conditions: Arm-specific actual treatment duration, cycle counts, discontinuation timing and dosing after pregnancy
Conditions for verification: Distinguish the maximum 6-month plan from actual treatment duration, ovulatory cycle counts, discontinuation and exposure after pregnancy confirmation.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Treatment duration under the monotherapy strategy must not be changed into the total length of pregnancy follow-up.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N13 · Are the length, end and completeness of pregnancy follow-up for live-birth ascertainment established?

Required materials and conditions: Arm-specific pregnancy/birth follow-up schedules, last contact, follow-up end and completeness
Conditions for verification: Distinguish treatment end from follow-up after pregnancy through birth and establish arm-specific follow-up start, end and completeness.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: The observation window for birth outcomes in the monotherapy comparison can differ from treatment duration.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N14 · Are the event definition, cumulative method and measurement unit of cumulative live birth sufficiently established?

Required materials and conditions: Endpoint definition, birth-verification procedures, cycle-accumulation rules and handling of multiple/repeated births
Conditions for verification: Establish the cumulative-live-birth label, gestational-age criteria, woman/infant unit, accumulation across cycles, multiple-birth handling and verification procedures.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Ovulation, pregnancy or infant counts must not be substituted for cumulative live birth per woman in the monotherapy comparison.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N15 · Are the original reported rates of 22% versus 36% accurately attributed to the monotherapy comparison?

Required materials and conditions: Attribution records linking each arm’s reported rate, name, original statement and result location
Conditions for verification: Link berberine 22% and letrozole 36% to the selected comparison and retain combination 34% as original context.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: This condition preserves observations for the monotherapy comparison without confusing reported rates across the three arms.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N16 · Are randomized, analyzed, completed and endpoint-observed denominators established for the two selected arms?

Required materials and conditions: CONSORT counts, analysis populations, birth-endpoint denominators and missing-data flow for the two selected arms
Conditions for verification: Distinguish the overall 644-participant allocation description from each selected arm’s randomized, analyzed, completed and endpoint-observed numbers.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Denominators for the two monotherapy arms must not be replaced by the overall 644 or by 644/3.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N17 · Are live-birth event counts and person/infant/cycle units established for the two selected arms?

Required materials and conditions: Original live-birth events, denominators, units and handling of repeated/multiple births
Conditions for verification: Establish original event counts and the person/infant/cycle units of their denominators without back-calculating reported rates.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Reported percentages alone cannot generate birth events or women for the monotherapy arms.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N18 · Are the effect of interest, ITT/PP and handling of intercurrent events established for the monotherapy-strategy comparison?

Required materials and conditions: Estimand specifications, ITT/PP populations and plans/results for intercurrent events and missing data
Conditions for verification: Define whether the effect concerns assigned monotherapy strategies or actual intake and establish handling of pregnancy, discontinuation, rescue treatment, missing data and ITT/PP.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Replacement-strategy effects and effects of actual monotherapy intake can differ.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N19 · Are the formal estimator, method, P and confidence interval for the selected between-arm effect established?

Required materials and conditions: Original between-arm effect estimates, model, P, confidence interval, denominator and endpoint time
Conditions for verification: Establish original estimates, uncertainty, denominator and time from an appropriate unadjusted or adjusted between-arm model.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Reported monotherapy rates must be distinguished from formal replacement-effect precision.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N20 · Are clinical importance and interpretation criteria for superiority, noninferiority or equivalence established for the selected comparison?

Required materials and conditions: Hypotheses, clinical-importance/noninferiority margins, effect confidence intervals and interpretation plans
Conditions for verification: Compare prespecified hypotheses and clinical-importance criteria with the corresponding confidence interval; do not convert nonsignificance or original no-benefit wording into equivalence.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: The unfavorable monotherapy direction and the magnitude/precision of clinically important differences require separate examination.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N21 · Are losses, missing data, incomplete birth follow-up and the effects of their handling established for the selected arms?

Required materials and conditions: Arm-specific losses, missing/incomplete pregnancy or birth follow-up, reasons, handling and sensitivity material
Conditions for verification: Establish arm-specific missing data, reasons for loss, unconfirmed births, analysis handling and sensitivity analyses.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Reported monotherapy-strategy rates can depend on handling of women not followed up.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N22 · Is consistency of preregistration, protocol and SAP with actual reporting established for the selected comparison?

Required materials and conditions: Actual ChiCTR/WHO registration versions, change histories, protocol, SAP and original result tables
Conditions for verification: Use the ChiCTR identifier as a lead to compare actual registration versions, timing, selected arms, endpoints and analysis plans with the original report.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: More than a registration number is needed to establish that this monotherapy comparison and analysis were prespecified.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N23 · Are multiplicity handling and hypothesis hierarchy established for the two derived comparisons in the 3-arm trial?

Required materials and conditions: 3-arm hypothesis hierarchy, multiplicity handling, comparison-specific SAP and reported results
Conditions for verification: Establish prespecified hierarchy and multiplicity handling for the monotherapy/add-on comparisons and examine reporting selection.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Splitting a 3-arm trial into two sheets still requires establishing the monotherapy comparison’s hypothesis hierarchy.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N24 · Are both the unfavorable monotherapy direction and the historical no-added-benefit statement retained?

Required materials and conditions: Preservation records of original results, counterviews, original assessment, axes and correction history
Conditions for verification: Retain all three-arm rates, original conclusions, D 34 and all axes without alteration rather than selecting favorable results only.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: The unfavorable monotherapy observation must not be covered over by metabolic possibilities or add-on results.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N25 · Are the ChiCTR link, exclusion of the wrong NCT and original unverified registration-field wording kept distinct?

Required materials and conditions: Linked records of PMID, DOI, ChiCTR, excluded NCT and the original registration field
Conditions for verification: Distinguish ChiCTR-TRC-09000376/PMID/DOI from the excluded NCT01116167 and retain the original registration field’s “not established” wording.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: These records prevent the monotherapy trial’s identity from being changed to an incorrect unrelated registration.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N26 · Is it explicit that the two derived sheets concern the same 3-arm trial and shared letrozole arm?

Required materials and conditions: Relationship records linking one study family, two comparisons, the shared control and report identifiers
Conditions for verification: Group the same PMID/DOI/ChiCTR into one study family and do not add the two sheets/shared control as independent trials or independent participants.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Displaying monotherapy and add-on comparisons as separate questions must not double-count one study’s control arm.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N27 · Are independent replication of the same question and the scope of access established?

Required materials and conditions: Identities, reports, search scope and original material for independently recruited studies
Conditions for verification: Establish separately recruited studies of the same population, exposure, comparator and live-birth endpoint and the actual reading/search scope.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Splitting the same 3-arm report into two sheets does not establish replication of the monotherapy replacement comparison.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N28 · Is there an applicable set for examining heterogeneity between distinct independent trials in the current retained material?

Required materials and conditions: Differences in populations, interventions, endpoints and analyses if additional independent families are established
Conditions for verification: Do not treat two comparisons in the same study family as between-trial heterogeneity; examine differences between trials when another eligible family is established.
Requirement and applicability: Supplementary; required when synthesizing multiple independent study families
Application exceptions: With only one family in the current retained set, between-trial heterogeneity is not applicable. Differences between comparisons within the study and dependence from the shared control remain subject to examination.
Why this condition is needed: The one family retained for the monotherapy comparison is not synthesized as multiple independent trials.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N29 · Are monotherapy dose response, longer-term effects and subgroup effects beyond the trial dose/duration established?

Required materials and conditions: Direct comparisons and interaction data for additional doses, durations, products and subgroups
Conditions for verification: Establish extensions beyond actual trial dose, duration and population using direct material and prespecified subgroup/interaction evidence.
Requirement and applicability: Supplementary; required when extending to other doses, durations or subgroups
Application exceptions: The narrow selected comparison does not always require evidence for every dose. Direct evidence is needed only for the extension being considered.
Why this condition is needed: The berberine 1.5 g/day monotherapy trial is not extended to replacement effects for all doses, forms and long-term exposures.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N30 · Is the boundary between live birth and ovulation, pregnancy, metabolic or weight outcomes maintained?

Required materials and conditions: Records of endpoint hierarchy and attribution boundaries for other outcomes
Conditions for verification: Fix the selected comparison to cumulative live birth; do not replace it with possible effects on ovulation, pregnancy rates, insulin or weight.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Birth results in the monotherapy arm must not be replaced by other intermediate outcomes.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N31 · Are funding, product support, author relationships and conflicts specifically established?

Required materials and conditions: Funding bodies, research funding, berberine/letrozole supply, author relationships and conflict declarations
Conditions for verification: Distinguish the public-research-network description from actual supporting institutions, product supply, author relationships and conflict declarations.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Funding/product influence on monotherapy replacement results must be examined through actual arm-specific support details.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N32 · Are actual maternal, pregnancy and fetal/neonatal harm collection and results established for the selected comparison?

Required materials and conditions: Arm-specific maternal/pregnancy/fetal/neonatal harm definitions, active collection, event/person denominators, timing, exposure, discontinuation and concomitant-treatment material
Conditions for verification: Establish arm-specific harm definitions, collection methods, exposure/follow-up timing, event/person denominators, discontinuations, concomitant treatment and actual results.
Requirement and applicability: Supplementary; required when explaining pregnancy safety or personal-use decisions
Application exceptions: The principal question concerns live-birth efficacy. Harm incidence is not imposed as an efficacy condition, while safety explanation and personal application require separate direct material.
Why this condition is needed: The monotherapy live-birth comparison alone cannot establish pregnancy safety, so separate harm information is needed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N33 · Are historical warnings, actual trial harms and personal-use decisions kept distinct?

Required materials and conditions: Records distinguishing the roles of original safety warnings and actual event material
Conditions for verification: Retain original warnings without promoting them to actual risk estimates, established causation, long-term safety or new personal dosing instructions.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: The monotherapy strategy’s live-birth result and the original pregnancy warning have different roles in the evidence.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N34 · Are the original review date, correction date, current sheet-review date and search/reading limits distinguished?

Required materials and conditions: Original review date, correction date, current review date, search scope and actual access records
Conditions for verification: Retain original review and correction dates, do not infer absent cutoff/individual access dates, and distinguish whether current new searches or external reading occurred.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Currency of the monotherapy comparison cannot be established by changing the original review date into a new search date.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N35 · Are English correction history, remaining generic wording and original null/empty values retained?

Required materials and conditions: Preservation records of original corrections, bilingual fields, empty values, absent fields and types
Conditions for verification: Do not fill the 1 correction or remaining generic verification wording with specific clinical values; retain empty detailed-claim lists/review notes, original axes and original types.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Generic English wording must not be read as new denominator, confidence-interval or funding facts for the monotherapy comparison.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

N36 · Are current retained-summary reading, unread external materials and historical matching statements separated by material type?

Required materials and conditions: Material-specific current acquisition/reading, URL, version, historical access date/level and original-location records
Conditions for verification: Distinguish actual reading of retained summaries from current unattempted/unread PubMed, DOI, paper, registration and SAP materials; do not inherit access levels/dates from a containing document.
Requirement and applicability: Required
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Why this condition is needed: Reading a monotherapy-comparison summary must not be represented as rereading the paper’s full text.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

Referenced methods and the sections actually reviewed

M03 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §3.1, §3.2.1–3.2.3, MECIR C5/C7/C13

Referenced principle: Clearly record the question, eligibility conditions and reasons for changes; distinguish intervention variants.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M04 · Cochrane Handbook 6.5.1 (2025), chapter updated 2025-03

Official methodology · §4.5, §4.6.1–4.6.3, MECIR C42

Referenced principle: Link studies and reports separately; do not omit studies solely because results are unreported.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M08 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §8.1–8.2.3, Table 8.2.a

Referenced principle: Fix the result and effect of interest when examining randomization, deviations, missingness, measurement and selective reporting.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M15 · Cochrane Handbook 6.5 (2024), chapter updated 2023-08

Official methodology · §15.2.4, §15.3.1–15.3.3

Referenced principle: Distinguish effect estimates, intervals, importance and applicability. Sample size alone does not determine precision.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

M19 · Cochrane Handbook 6.5 (2024), chapter updated 2019-10

Official methodology · §19.1.2, §19.2.1–19.2.4

Referenced principle: Harm questions may require different designs, populations and follow-up from efficacy questions. Case reports do not establish incidence.
Extent of review: Retained method-application records were reused. External originals were not reread and method content was not reassessed.

What the statuses mean

Met: The row’s narrow record, attribution, boundary or actual fact was checked. This does not certify efficacy, precision or safety.
Partly verified: Some required information is available, but actual exposure, definitions, denominators or other necessary material remain missing.
Unverified: The criterion cannot be established within the retained scope. This does not mean 0 effect, 0 studies or failed access.
Not applicable: The condition has no applicable subject within the current retained set and narrow question. This does not replace a material gap or unread status.
Not reported: Limited to the particular material or section actually read. It is not extended to the entirety of an unread external paper.
Review incomplete: A status for external original-material comparison not yet performed, distinguished from review of locally retained content.

Change history

2026-10-27 · Public page/material version 1.0

The public view and materials were prepared from the existing 36 items. No new clinical search, verification-state change or scoring was performed.

The stored-material review date (2026-10-05) and original evidence review date (2026-09-08) were retained unchanged.

Researcher downloads

These materials provide the same evidence, scope and verification status as this page.

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N01 · Is the question fixed to cumulative live birth with berberine alone versus letrozole alone?

Current findings: The original claim concerns cumulative live birth in infertile women with PCOS. This sheet concerns berberine alone versus letrozole alone; the original detailed-claim list is empty.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The original claim and derived-comparison boundary match the current input and formal assignment. The derived ID was not turned into an index in the original detailed-claim list.
Reason for missing information: This is a boundary-record condition, separate from establishing a clinical effect.
Required materials and conditions: Linked records of the original claim, intervention, comparator and derived-comparison boundary
Materials to obtain first: Linked records of the original claim, intervention, comparator and derived-comparison boundary
Further research: If the boundary changes, redefine the actual intervention/comparator combination and review it in a separate version.
Remaining uncertainty: This is a boundary-record condition, separate from establishing a clinical effect. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Retain the original claim and explicitly identify berberine alone versus letrozole alone as a derived comparison.
Why this condition is needed: Separating a treatment-replacement question from an add-on question prevents monotherapy results from being read as combination effects.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N02 · Are the two monotherapy arms and the roles of double-dummy placebos distinguished in the retained account?

Current findings: The retained account describes double-dummy berberine/placebo and letrozole/placebo and a 3-arm RCT. The selected comparison is berberine alone versus letrozole alone.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The selected arms’ roles can be distinguished in the current description. Actual success of blinding has not been established.
Reason for missing information: Detailed placebo implementation and successful blinding are separate gaps.
Required materials and conditions: Records of active ingredients, placebo allocation and actual comparator roles in the 3 arms
Materials to obtain first: Records of active ingredients, placebo allocation and actual comparator roles in the 3 arms
Further research: If the full protocol is obtained, compare active/placebo allocation by arm and keep different strategies distinct.
Remaining uncertainty: Detailed placebo implementation and successful blinding are separate gaps. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Select berberine alone and letrozole alone; do not read the double dummy as a pure no-treatment placebo arm.
Why this condition is needed: Changing the active letrozole comparator into a no-treatment comparator changes the meaning of the replacement strategy.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N03 · Are the trial berberine’s exact salt form, source, product and standardization established?

Current findings: The original claim conditions leave the exact salt form and plant source unverified. The retained account also keeps berberine hydrochloride, plant extracts, combination formulas and other derivatives distinct.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The exact product form and standardization cannot be established from the retained material.
Reason for missing information: Product identifier, manufacturer, salt form and batch are absent.
Required materials and conditions: Berberine product name, manufacturer, salt form, batch and standardization material
Materials to obtain first: Berberine product name, manufacturer, salt form, batch and standardization material
Further research: If original product material is obtained, compare composition and standardization and review unmatched products as separate questions.
Remaining uncertainty: Product identifier, manufacturer, salt form and batch are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish the exact chemical form, product identifier, source, content standardization and application to the selected arm.
Why this condition is needed: Product matching prevents monotherapy replacement results from being transferred to arbitrary berberine hydrochloride or plant products.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N04 · Are the planned oral berberine monotherapy dose, actual intake and adherence established?

Current findings: The oral route and planned berberine 1.5 g/day are specified. Actual intake, adherence and discontinuation details are absent from current material.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The planned oral dose is established, while actual individual exposure is not.
Reason for missing information: Actual administration, adherence and the distribution of discontinuations remain unverified.
Required materials and conditions: Arm-specific prescriptions, adherence, actual daily doses and discontinuation records
Materials to obtain first: Arm-specific prescriptions, adherence, actual daily doses and discontinuation records
Further research: Use dosing records to distinguish planned from actual exposure and compare the effects of deviations with the predefined analysis.
Remaining uncertainty: Actual administration, adherence and the distribution of discontinuations remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish planned oral 1.5 g/day from actual intake, adherence, discontinuation and changes.
Why this condition is needed: It is necessary to know whether actual exposure under the monotherapy strategy matched the planned dose.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N05 · Are the active letrozole comparator’s planned dosing, escalation and actual administration established?

Current findings: The plan of 2.5 mg on cycle days 3–7, increasing to 5 mg if needed, is retained. Actual escalation, cycle counts and adherence by arm are unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The comparator drug’s plan is established, but actual administration records are unverified.
Reason for missing information: Actual arm-specific escalation and cycle counts are absent.
Required materials and conditions: Comparator-arm letrozole prescriptions by cycle, dose escalation and actual intake records
Materials to obtain first: Comparator-arm letrozole prescriptions by cycle, dose escalation and actual intake records
Further research: Compare actual comparator dosing by cycle with the planned escalation criteria.
Remaining uncertainty: Actual arm-specific escalation and cycle counts are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish planned comparator letrozole 2.5 mg on cycle days 3–7, increasing to 5 mg if needed, alongside actual escalation and administration.
Why this condition is needed: Unclear actual exposure to the active replacement comparator limits interpretation of the monotherapy-strategy comparison.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N06 · Are the actual population and Rotterdam PCOS/infertility eligibility criteria sufficiently established for the selected comparison?

Current findings: The recruited population is described as 644 infertile women meeting Rotterdam PCOS criteria. Detailed diagnosis, age, infertility duration and exclusions are absent from current material.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The principal population category is established, while detailed eligibility and arm-specific characteristics remain unverified.
Reason for missing information: The 644 describes the overall population, not the analysis denominator of either selected arm.
Required materials and conditions: Diagnosis, age, infertility duration, inclusion/exclusion criteria and arm-specific population characteristics
Materials to obtain first: Diagnosis, age, infertility duration, inclusion/exclusion criteria and arm-specific population characteristics
Further research: If eligibility criteria and baseline tables are obtained, compare the target population with the actual trial population.
Remaining uncertainty: The 644 describes the overall population, not the analysis denominator of either selected arm. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish the description of infertile women with Rotterdam PCOS and the detailed diagnostic, age and eligibility criteria.
Why this condition is needed: Population conditions prevent extension of this monotherapy comparison to other infertility causes or women generally.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N07 · Are baseline infertility causes, prior treatment and arm-specific prognostic characteristics established?

Current findings: Current material describes infertile women with Rotterdam PCOS but provides no tables of baseline causes, previous treatment or arm-specific characteristics.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Material needed to establish baseline prognostic balance in the selected arms is absent.
Reason for missing information: Exclusion of other infertility causes and treatment histories remain unverified.
Required materials and conditions: Arm-specific baseline tables, investigations of infertility causes, prior treatment and medical histories
Materials to obtain first: Arm-specific baseline tables, investigations of infertility causes, prior treatment and medical histories
Further research: Compare baseline material with planned handling of prognostic variables and actual balance.
Remaining uncertainty: Exclusion of other infertility causes and treatment histories remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish prognosis in the selected arms, including male/tubal factors, baseline ovulatory/metabolic status and previous treatment.
Why this condition is needed: Actual data are needed to examine baseline prognostic balance when comparing the monotherapy replacement strategies.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N08 · Are actual random-sequence generation and implementation of the allocation ratio established in this multicenter trial?

Current findings: A multicenter double-blind 3-arm RCT with 644 participants and 1:1:1 allocation is described. Sequence generation, stratification and site-specific implementation remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The design and allocation ratio are described, but actual randomization procedures are not established.
Reason for missing information: Detailed sequence generation, stratification and allocation by site are absent.
Required materials and conditions: Random-sequence generation, stratification, site-specific allocation procedures and CONSORT flow material
Materials to obtain first: Random-sequence generation, stratification, site-specific allocation procedures and CONSORT flow material
Further research: Compare the protocol and allocation procedures to examine implementation of randomization for the selected arms.
Remaining uncertainty: Detailed sequence generation, stratification and allocation by site are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish not only the multicenter RCT and 1:1:1 description but also sequence generation, stratification and site-specific implementation.
Why this condition is needed: More than the allocation description is needed to assess selection bias in the two monotherapy arms.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N09 · Are allocation concealment and recruitment procedures established for the two selected arms?

Current findings: The current summary describes an RCT but lacks details of allocation concealment, enrollment sequence and recruitment implementation.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The label randomized trial cannot substitute for actual implementation of allocation concealment.
Reason for missing information: Allocation-concealment documents and recruitment records remain unverified.
Required materials and conditions: Allocation concealment, enrollment timing, recruitment sequence and actual implementation material
Materials to obtain first: Allocation concealment, enrollment timing, recruitment sequence and actual implementation material
Further research: Obtain allocation/enrollment documents to examine concealment procedures in relation to recruitment timing.
Remaining uncertainty: Allocation-concealment documents and recruitment records remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish recruitment before allocation disclosure, concealment methods and actual implementation in the selected arms.
Why this condition is needed: Recruitment bias from predictable allocation also needs examination in an active-treatment replacement comparison.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N10 · Are actual double-dummy blinding and the independence of live-birth ascertainment established?

Current findings: Multicenter double blinding and a double dummy are described. Placebo appearance, actual maintenance of blinding and the persons/procedures confirming births remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The planned design is described, but actual blinding and ascertainment implementation are not established.
Reason for missing information: Maintenance of blinding and outcome-verification procedures are absent.
Required materials and conditions: Placebo matching, maintenance/breaking of blinding, outcome assessors and verification procedures
Materials to obtain first: Placebo matching, maintenance/breaking of blinding, outcome assessors and verification procedures
Further research: Compare protocol and ascertainment documents to examine implementation of blinding and independence of outcome assessment.
Remaining uncertainty: Maintenance of blinding and outcome-verification procedures are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish the double-blind/double-dummy description, placebo matching, unblinding or guessability and birth-ascertainment procedures.
Why this condition is needed: These conditions examine dosing, subsequent treatment and ascertainment deviations in the comparison of two different active drugs.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N11 · Are concomitant/rescue treatments and deviations established in the two monotherapy-strategy arms?

Current findings: The current summary gives only selected-arm names and planned doses; actual concomitant/rescue treatment, crossover and reasons for discontinuation are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Material needed to establish differences in other treatments within the selected comparison is absent.
Reason for missing information: Actual concomitant/rescue treatments and deviations remain unverified.
Required materials and conditions: Arm-specific concomitant/rescue treatment, crossover, other infertility treatment and reasons for discontinuation
Materials to obtain first: Arm-specific concomitant/rescue treatment, crossover, other infertility treatment and reasons for discontinuation
Further research: Reconstruct arm-specific treatment pathways to examine the definition of the effect of interest and appropriate handling of deviations.
Remaining uncertainty: Actual concomitant/rescue treatments and deviations remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish actual concomitant/rescue and other infertility treatments and differences between the two monotherapy arms.
Why this condition is needed: Different subsequent treatments can prevent attribution solely to replacement with the monotherapy drug.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N12 · Are the maximum 6-month plan, actual individual treatment/cycle counts and exposure after pregnancy established?

Current findings: A maximum 6 months and pregnancy-outcome follow-up are described as a plan. Actual individual administration, cycle counts, discontinuation and exposure after pregnancy remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The duration plan is established, but actual exposure length and discontinuation pathways are not.
Reason for missing information: The maximum 6 months is not read as every woman’s actual exposure or the end of pregnancy follow-up.
Required materials and conditions: Arm-specific actual treatment duration, cycle counts, discontinuation timing and dosing after pregnancy
Materials to obtain first: Arm-specific actual treatment duration, cycle counts, discontinuation timing and dosing after pregnancy
Further research: Distinguish the treatment calendar from pregnancy follow-up and examine actual exposure duration and discontinuation pathways.
Remaining uncertainty: The maximum 6 months is not read as every woman’s actual exposure or the end of pregnancy follow-up. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish the maximum 6-month plan from actual treatment duration, ovulatory cycle counts, discontinuation and exposure after pregnancy confirmation.
Why this condition is needed: Treatment duration under the monotherapy strategy must not be changed into the total length of pregnancy follow-up.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N13 · Are the length, end and completeness of pregnancy follow-up for live-birth ascertainment established?

Current findings: The original claim conditions state a maximum 6 months with pregnancy-outcome follow-up, but length through birth, arm-specific follow-up end and completeness are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The exact observation window used to establish birth outcomes cannot be determined from current material.
Reason for missing information: Pregnancy follow-up length and completeness remain unverified.
Required materials and conditions: Arm-specific pregnancy/birth follow-up schedules, last contact, follow-up end and completeness
Materials to obtain first: Arm-specific pregnancy/birth follow-up schedules, last contact, follow-up end and completeness
Further research: Compare the observation window from pregnancy onset to birth confirmation with incomplete follow-up.
Remaining uncertainty: Pregnancy follow-up length and completeness remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish treatment end from follow-up after pregnancy through birth and establish arm-specific follow-up start, end and completeness.
Why this condition is needed: The observation window for birth outcomes in the monotherapy comparison can differ from treatment duration.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N14 · Are the event definition, cumulative method and measurement unit of cumulative live birth sufficiently established?

Current findings: Cumulative live birth during treatment is specified as the principal endpoint. Gestational-age criteria, woman/infant units, multiple births and cumulative counting rules remain unverified.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The principal endpoint label is established, but actual event definition and unit are not sufficiently established.
Reason for missing information: Event definition, unit and verification procedures remain unverified.
Required materials and conditions: Endpoint definition, birth-verification procedures, cycle-accumulation rules and handling of multiple/repeated births
Materials to obtain first: Endpoint definition, birth-verification procedures, cycle-accumulation rules and handling of multiple/repeated births
Further research: Obtain endpoint specifications to examine consistency of woman, cycle and infant units with cumulative counting.
Remaining uncertainty: Event definition, unit and verification procedures remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish the cumulative-live-birth label, gestational-age criteria, woman/infant unit, accumulation across cycles, multiple-birth handling and verification procedures.
Why this condition is needed: Ovulation, pregnancy or infant counts must not be substituted for cumulative live birth per woman in the monotherapy comparison.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N15 · Are the original reported rates of 22% versus 36% accurately attributed to the monotherapy comparison?

Current findings: The original results are letrozole 36%, combination 34% and berberine 22%. The selected monotherapy comparison is berberine 22% versus letrozole 36%; no new difference or statistic was calculated.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The narrow attribution of arm names and reported rates matches the retained account. This does not establish formal between-arm effects or precision.
Reason for missing information: Arm-specific events, denominators and formal effect estimates remain separately unverified.
Required materials and conditions: Attribution records linking each arm’s reported rate, name, original statement and result location
Materials to obtain first: Attribution records linking each arm’s reported rate, name, original statement and result location
Further research: When new reports are obtained, first verify arm names for the same endpoint, denominator and time, then compare with existing attribution.
Remaining uncertainty: Arm-specific events, denominators and formal effect estimates remain separately unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Link berberine 22% and letrozole 36% to the selected comparison and retain combination 34% as original context.
Why this condition is needed: This condition preserves observations for the monotherapy comparison without confusing reported rates across the three arms.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N16 · Are randomized, analyzed, completed and endpoint-observed denominators established for the two selected arms?

Current findings: Only 644 participants overall and 1:1:1 allocation are described. Arm-specific randomized, analyzed, completed and birth-observed denominators are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The overall count and allocation ratio do not establish actual integer denominators for each arm.
Reason for missing information: Do not use a 644/3 calculation or denominators from the other sheet.
Required materials and conditions: CONSORT counts, analysis populations, birth-endpoint denominators and missing-data flow for the two selected arms
Materials to obtain first: CONSORT counts, analysis populations, birth-endpoint denominators and missing-data flow for the two selected arms
Further research: Compare definitions of each denominator to distinguish overall allocation from the endpoint-analysis population.
Remaining uncertainty: Do not use a 644/3 calculation or denominators from the other sheet. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish the overall 644-participant allocation description from each selected arm’s randomized, analyzed, completed and endpoint-observed numbers.
Why this condition is needed: Denominators for the two monotherapy arms must not be replaced by the overall 644 or by 644/3.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N17 · Are live-birth event counts and person/infant/cycle units established for the two selected arms?

Current findings: The original results contain only three-arm percentages; original live-birth events, denominators and repeated/multiple-birth handling are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Percentages alone cannot establish actual event counts or units.
Reason for missing information: No new back-calculation, rounded event counts or application of a 644 denominator is performed.
Required materials and conditions: Original live-birth events, denominators, units and handling of repeated/multiple births
Materials to obtain first: Original live-birth events, denominators, units and handling of repeated/multiple births
Further research: Obtain original result tables to examine the relation between events and person/cycle denominators.
Remaining uncertainty: No new back-calculation, rounded event counts or application of a 644 denominator is performed. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish original event counts and the person/infant/cycle units of their denominators without back-calculating reported rates.
Why this condition is needed: Reported percentages alone cannot generate birth events or women for the monotherapy arms.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N18 · Are the effect of interest, ITT/PP and handling of intercurrent events established for the monotherapy-strategy comparison?

Current findings: The current summary gives only the principal endpoint and arm-level reported rates; estimand, ITT/PP and specifications for intercurrent events or missing data are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The effect of interest and actual analysis population for the selected comparison have not been established.
Reason for missing information: The distinction between monotherapy/add-on strategy effects and actual-intake effects remains unverified.
Required materials and conditions: Estimand specifications, ITT/PP populations and plans/results for intercurrent events and missing data
Materials to obtain first: Estimand specifications, ITT/PP populations and plans/results for intercurrent events and missing data
Further research: After establishing the estimand and analysis populations, examine how pregnancy, discontinuation and rescue treatment enter the definition.
Remaining uncertainty: The distinction between monotherapy/add-on strategy effects and actual-intake effects remains unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Define whether the effect concerns assigned monotherapy strategies or actual intake and establish handling of pregnancy, discontinuation, rescue treatment, missing data and ITT/PP.
Why this condition is needed: Replacement-strategy effects and effects of actual monotherapy intake can differ.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N19 · Are the formal estimator, method, P and confidence interval for the selected between-arm effect established?

Current findings: Current material contains only arm-specific percentages; the formal effect estimator, model, P and confidence interval for the selected comparison are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Reported rates are established, but material needed to establish formal comparison estimates and confidence intervals is absent.
Reason for missing information: No new difference, RR, OR, NNT, CI or P is calculated.
Required materials and conditions: Original between-arm effect estimates, model, P, confidence interval, denominator and endpoint time
Materials to obtain first: Original between-arm effect estimates, model, P, confidence interval, denominator and endpoint time
Further research: Compare original analysis tables and the SAP to establish comparison estimates and precision. Do not exclude an unadjusted analysis solely because it is unadjusted.
Remaining uncertainty: No new difference, RR, OR, NNT, CI or P is calculated. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish original estimates, uncertainty, denominator and time from an appropriate unadjusted or adjusted between-arm model.
Why this condition is needed: Reported monotherapy rates must be distinguished from formal replacement-effect precision.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N20 · Are clinical importance and interpretation criteria for superiority, noninferiority or equivalence established for the selected comparison?

Current findings: The retained account describes a lower live-birth direction with monotherapy. Importance criteria, superiority/noninferiority/equivalence hypotheses and confidence intervals remain unverified.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The original conclusion’s direction alone cannot newly establish clinical importance, equivalence or 0 effect.
Reason for missing information: Prespecified margins, confidence intervals and clinical-importance criteria are absent.
Required materials and conditions: Hypotheses, clinical-importance/noninferiority margins, effect confidence intervals and interpretation plans
Materials to obtain first: Hypotheses, clinical-importance/noninferiority margins, effect confidence intervals and interpretation plans
Further research: Establish original hypotheses and margins, then examine how confidence intervals address clinically important differences.
Remaining uncertainty: Prespecified margins, confidence intervals and clinical-importance criteria are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Compare prespecified hypotheses and clinical-importance criteria with the corresponding confidence interval; do not convert nonsignificance or original no-benefit wording into equivalence.
Why this condition is needed: The unfavorable monotherapy direction and the magnitude/precision of clinically important differences require separate examination.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N21 · Are losses, missing data, incomplete birth follow-up and the effects of their handling established for the selected arms?

Current findings: The current summary lacks counts of losses, missing data and incomplete birth follow-up, their handling and sensitivity results.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Material needed to establish how missing-data handling affects reported arm-level rates is absent.
Reason for missing information: Missing data are not treated as 0 events or complete follow-up.
Required materials and conditions: Arm-specific losses, missing/incomplete pregnancy or birth follow-up, reasons, handling and sensitivity material
Materials to obtain first: Arm-specific losses, missing/incomplete pregnancy or birth follow-up, reasons, handling and sensitivity material
Further research: Examine consistency between missing-data flow and planned handling and establish the scope of original sensitivity analyses.
Remaining uncertainty: Missing data are not treated as 0 events or complete follow-up. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish arm-specific missing data, reasons for loss, unconfirmed births, analysis handling and sensitivity analyses.
Why this condition is needed: Reported monotherapy-strategy rates can depend on handling of women not followed up.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N22 · Is consistency of preregistration, protocol and SAP with actual reporting established for the selected comparison?

Current findings: ChiCTR-TRC-09000376 and a historical statement matching the paper with WHO/ChiCTR are retained. Actual registration versions, SAP and change history have not currently been acquired or read.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The identifier and historical matching statement alone do not establish consistency between actual prior plans and reporting.
Reason for missing information: Registration timing, protocol, SAP and change history remain unverified.
Required materials and conditions: Actual ChiCTR/WHO registration versions, change histories, protocol, SAP and original result tables
Materials to obtain first: Actual ChiCTR/WHO registration versions, change histories, protocol, SAP and original result tables
Further research: If registration and SAP are obtained, compare registration timing, hypotheses, arms, endpoints and analyses with reporting.
Remaining uncertainty: Registration timing, protocol, SAP and change history remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Use the ChiCTR identifier as a lead to compare actual registration versions, timing, selected arms, endpoints and analysis plans with the original report.
Why this condition is needed: More than a registration number is needed to establish that this monotherapy comparison and analysis were prespecified.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N23 · Are multiplicity handling and hypothesis hierarchy established for the two derived comparisons in the 3-arm trial?

Current findings: The original material describes a 3-arm RCT but lacks the two comparisons’ prespecified hierarchy, multiplicity handling and selection from all results.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Producing two sheets does not establish the trial’s hypotheses or handling of multiplicity.
Reason for missing information: Comparison hierarchy and multiplicity handling remain unverified.
Required materials and conditions: 3-arm hypothesis hierarchy, multiplicity handling, comparison-specific SAP and reported results
Materials to obtain first: 3-arm hypothesis hierarchy, multiplicity handling, comparison-specific SAP and reported results
Further research: Compare the original SAP with complete results to examine comparison selection and multiplicity handling.
Remaining uncertainty: Comparison hierarchy and multiplicity handling remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish prespecified hierarchy and multiplicity handling for the monotherapy/add-on comparisons and examine reporting selection.
Why this condition is needed: Splitting a 3-arm trial into two sheets still requires establishing the monotherapy comparison’s hypothesis hierarchy.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N24 · Are both the unfavorable monotherapy direction and the historical no-added-benefit statement retained?

Current findings: The original three-arm rates, statements that monotherapy was lower and addition did not increase live birth, the separate metabolic counterview, D 34 and all axes are retained.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The current input’s unfavorable direction, counterview and assessment were not deleted or recalculated. This is not new certification of clinical effects.
Reason for missing information: Formal comparison statistics and precision remain unverified.
Required materials and conditions: Preservation records of original results, counterviews, original assessment, axes and correction history
Materials to obtain first: Preservation records of original results, counterviews, original assessment, axes and correction history
Further research: If subsequent reports become available, compare favorable, unfavorable and no-benefit material under the same attribution rules and record changes as separate events.
Remaining uncertainty: Formal comparison statistics and precision remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Retain all three-arm rates, original conclusions, D 34 and all axes without alteration rather than selecting favorable results only.
Why this condition is needed: The unfavorable monotherapy observation must not be covered over by metabolic possibilities or add-on results.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N25 · Are the ChiCTR link, exclusion of the wrong NCT and original unverified registration-field wording kept distinct?

Current findings: The bibliography lists PMID 27336209, DOI 10.1016/j.fertnstert.2016.05.022 and ChiCTR-TRC-09000376. The original central point excludes NCT01116167, while the evidence-table registration field remains “not established.”
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The established historical identifier link and the original field’s unverified label are retained separately. Current external registration verification is not complete.
Reason for missing information: Current comparison with original registration material was not attempted.
Required materials and conditions: Linked records of PMID, DOI, ChiCTR, excluded NCT and the original registration field
Materials to obtain first: Linked records of PMID, DOI, ChiCTR, excluded NCT and the original registration field
Further research: If actual registration material is obtained, compare identifiers, population, 3 arms and endpoints and record discrepancies as separate correction events.
Remaining uncertainty: Current comparison with original registration material was not attempted. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish ChiCTR-TRC-09000376/PMID/DOI from the excluded NCT01116167 and retain the original registration field’s “not established” wording.
Why this condition is needed: These records prevent the monotherapy trial’s identity from being changed to an incorrect unrelated registration.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N26 · Is it explicit that the two derived sheets concern the same 3-arm trial and shared letrozole arm?

Current findings: The retained original set contains 1 3-arm RCT report. Both sheets share the same 644-participant trial and letrozole control and are not counted as independent repeated trials or two participant populations.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The two comparisons and shared-control relationship within the same report are explicit.
Reason for missing information: Exact comparison-specific analysis denominators and covariance remain separately unverified.
Required materials and conditions: Relationship records linking one study family, two comparisons, the shared control and report identifiers
Materials to obtain first: Relationship records linking one study family, two comparisons, the shared control and report identifiers
Further research: Compare report populations, recruitment and identifiers to link the same family and duplicated controls.
Remaining uncertainty: Exact comparison-specific analysis denominators and covariance remain separately unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Group the same PMID/DOI/ChiCTR into one study family and do not add the two sheets/shared control as independent trials or independent participants.
Why this condition is needed: Displaying monotherapy and add-on comparisons as separate questions must not double-count one study’s control arm.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N27 · Are independent replication of the same question and the scope of access established?

Current findings: The current retained set contains 1 direct 3-arm trial report, and no new clinical search was performed. Material establishing independent replication is absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Having one retained report does not prove that only one human study, or no human studies, exist worldwide.
Reason for missing information: Independent replication of the same question and comprehensive search scope remain unverified.
Required materials and conditions: Identities, reports, search scope and original material for independently recruited studies
Materials to obtain first: Identities, reports, search scope and original material for independently recruited studies
Further research: If new-material review is authorized, assess question-specific eligibility and compare independent recruitment and report overlap.
Remaining uncertainty: Independent replication of the same question and comprehensive search scope remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish separately recruited studies of the same population, exposure, comparator and live-birth endpoint and the actual reading/search scope.
Why this condition is needed: Splitting the same 3-arm report into two sheets does not establish replication of the monotherapy replacement comparison.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N28 · Is there an applicable set for examining heterogeneity between distinct independent trials in the current retained material?

Current findings: The current retained report set contains only 1 direct 3-arm trial, and the two derived sheets belong to the same family. Multiple families needed for between-independent-trial heterogeneity are absent from this set.
Verification status: Not applicable
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: There is no narrow applicable set for between-independent-trial heterogeneity in the current retained material. Unverified replication, denominators or precision are not changed to not applicable.
Reason for missing information: Whether other studies exist remains separately unverified.
Required materials and conditions: Differences in populations, interventions, endpoints and analyses if additional independent families are established
Materials to obtain first: Differences in populations, interventions, endpoints and analyses if additional independent families are established
Further research: If a separate family is obtained, compare question matching and design, population and estimator differences to examine whether synthesis is appropriate.
Remaining uncertainty: Whether other studies exist remains separately unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Do not treat two comparisons in the same study family as between-trial heterogeneity; examine differences between trials when another eligible family is established.
Why this condition is needed: The one family retained for the monotherapy comparison is not synthesized as multiple independent trials.
Application exceptions: With only one family in the current retained set, between-trial heterogeneity is not applicable. Differences between comparisons within the study and dependence from the shared control remain subject to examination.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N29 · Are monotherapy dose response, longer-term effects and subgroup effects beyond the trial dose/duration established?

Current findings: Current material describes berberine 1.5 g/day, a maximum 6-month plan and results in specific infertile women with PCOS. Direct material for other doses, longer durations and subgroups is absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Current material does not establish extended effects. This gap differs from the formal effect of the narrow selected comparison.
Reason for missing information: Extensions beyond the trial dose, duration and population remain unverified.
Required materials and conditions: Direct comparisons and interaction data for additional doses, durations, products and subgroups
Materials to obtain first: Direct comparisons and interaction data for additional doses, durations, products and subgroups
Further research: When an extension question is needed, review its material as a separate question; do not read simple subgroup differences as interactions.
Remaining uncertainty: Extensions beyond the trial dose, duration and population remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish extensions beyond actual trial dose, duration and population using direct material and prespecified subgroup/interaction evidence.
Why this condition is needed: The berberine 1.5 g/day monotherapy trial is not extended to replacement effects for all doses, forms and long-term exposures.
Application exceptions: The narrow selected comparison does not always require evidence for every dose. Direct evidence is needed only for the extension being considered.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N30 · Is the boundary between live birth and ovulation, pregnancy, metabolic or weight outcomes maintained?

Current findings: The original explanation and summary state that only live birth is assessed and that ovulation, pregnancy rates, insulin and weight are separate. This sheet maintains that boundary.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The narrow record condition of keeping the principal birth endpoint distinct from other intermediate outcomes is established.
Reason for missing information: Actual effects on other outcomes are not newly assessed in this sheet.
Required materials and conditions: Records of endpoint hierarchy and attribution boundaries for other outcomes
Materials to obtain first: Records of endpoint hierarchy and attribution boundaries for other outcomes
Further research: If material on other outcomes is obtained, review those questions separately and interpret their relationship to live birth only where direct linking evidence exists.
Remaining uncertainty: Actual effects on other outcomes are not newly assessed in this sheet. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Fix the selected comparison to cumulative live birth; do not replace it with possible effects on ovulation, pregnancy rates, insulin or weight.
Why this condition is needed: Birth results in the monotherapy arm must not be replaced by other intermediate outcomes.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N31 · Are funding, product support, author relationships and conflicts specifically established?

Current findings: The original funding field says “public research network; details of product support to be checked.” Exact institutions, product providers, author relationships and conflict details are absent from current material.
Verification status: Partly verified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The support category is described, while product-support and conflict details are not established. Generic English wording does not replace actual declaration content.
Reason for missing information: Detailed supporting institutions, providers, author relationships and declarations remain unverified.
Required materials and conditions: Funding bodies, research funding, berberine/letrozole supply, author relationships and conflict declarations
Materials to obtain first: Funding bodies, research funding, berberine/letrozole supply, author relationships and conflict declarations
Further research: Compare original support and conflict statements to establish research funding, product provision and author relationships separately.
Remaining uncertainty: Detailed supporting institutions, providers, author relationships and declarations remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish the public-research-network description from actual supporting institutions, product supply, author relationships and conflict declarations.
Why this condition is needed: Funding/product influence on monotherapy replacement results must be examined through actual arm-specific support details.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N32 · Are actual maternal, pregnancy and fetal/neonatal harm collection and results established for the selected comparison?

Current findings: The retained account contains warnings about trying to conceive and fetal/neonatal bilirubin. Actual harm events, person denominators, timing, collection, discontinuation and comparative risks for the selected arms are absent.
Verification status: Unverified
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Warning statements do not replace confirmation of actual trial harm collection and incidence.
Reason for missing information: Actual harms, incidence, exposure after pregnancy and long-term safety remain unverified; no new calculation is performed.
Required materials and conditions: Arm-specific maternal/pregnancy/fetal/neonatal harm definitions, active collection, event/person denominators, timing, exposure, discontinuation and concomitant-treatment material
Materials to obtain first: Arm-specific maternal/pregnancy/fetal/neonatal harm definitions, active collection, event/person denominators, timing, exposure, discontinuation and concomitant-treatment material
Further research: If original safety material is obtained, compare harm definitions, collection, follow-up, denominators and discontinuation/concomitant treatment to distinguish signals from comparative risks.
Remaining uncertainty: Actual harms, incidence, exposure after pregnancy and long-term safety remain unverified; no new calculation is performed. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Establish arm-specific harm definitions, collection methods, exposure/follow-up timing, event/person denominators, discontinuations, concomitant treatment and actual results.
Why this condition is needed: The monotherapy live-birth comparison alone cannot establish pregnancy safety, so separate harm information is needed.
Application exceptions: The principal question concerns live-birth efficacy. Harm incidence is not imposed as an efficacy condition, while safety explanation and personal application require separate direct material.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N33 · Are historical warnings, actual trial harms and personal-use decisions kept distinct?

Current findings: The original safety warning and advice to consult a clinician are retained as historical text. This sheet does not turn them into new incidence estimates, established causation, safety at every dose or personal dosing instructions.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: The narrow record condition distinguishing historical warnings from this sheet’s material-verification scope is established.
Reason for missing information: Actual risk estimates and personal-application decisions remain unverified.
Required materials and conditions: Records distinguishing the roles of original safety warnings and actual event material
Materials to obtain first: Records distinguishing the roles of original safety warnings and actual event material
Further research: If original safety material is added, establish the warning’s basis, population and events and examine these separately from comparative risk.
Remaining uncertainty: Actual risk estimates and personal-application decisions remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Retain original warnings without promoting them to actual risk estimates, established causation, long-term safety or new personal dosing instructions.
Why this condition is needed: The monotherapy strategy’s live-birth result and the original pregnancy warning have different roles in the evidence.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N34 · Are the original review date, correction date, current sheet-review date and search/reading limits distinguished?

Current findings: The original verdict review date is 2026-09-08 and the correction date is 2026-09-14. This sheet’s record-review date is 2026-10-05; no new clinical search or external reading was performed. Original search-cutoff and report-specific access-date fields are absent.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Different dates and the actual current reading scope are recorded separately. This does not establish a completed comprehensive current search.
Reason for missing information: Individual external access dates and search cutoff are not inferred where original fields are absent.
Required materials and conditions: Original review date, correction date, current review date, search scope and actual access records
Materials to obtain first: Original review date, correction date, current review date, search scope and actual access records
Further research: When new evidence updating is authorized, record search dates, scope and access events as new records without backdating historical dates.
Remaining uncertainty: Individual external access dates and search cutoff are not inferred where original fields are absent. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Retain original review and correction dates, do not infer absent cutoff/individual access dates, and distinguish whether current new searches or external reading occurred.
Why this condition is needed: Currency of the monotherapy comparison cannot be established by changing the original review date into a new search date.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N35 · Are English correction history, remaining generic wording and original null/empty values retained?

Current findings: The record describes a 2026-09-14 correction of 1 generic English field while retaining grade, score and date. Remaining generic sample-size, funding and result English wording, empty detailed-claim lists/review notes and the complete original material are retained.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Specific translations remain distinguished from generic verification wording, without generating absent numbers, confidence intervals or funding declarations.
Reason for missing information: Remaining generic wording does not establish the corresponding actual clinical values.
Required materials and conditions: Preservation records of original corrections, bilingual fields, empty values, absent fields and types
Materials to obtain first: Preservation records of original corrections, bilingual fields, empty values, absent fields and types
Further research: If a new bilingual correction is needed, establish corresponding original values and the correction event and preserve the entire text before change.
Remaining uncertainty: Remaining generic wording does not establish the corresponding actual clinical values. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Do not fill the 1 correction or remaining generic verification wording with specific clinical values; retain empty detailed-claim lists/review notes, original axes and original types.
Why this condition is needed: Generic English wording must not be read as new denominator, confidence-interval or funding facts for the monotherapy comparison.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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N36 · Are current retained-summary reading, unread external materials and historical matching statements separated by material type?

Current findings: The complete bilingual account, evidence, bibliography and corrections in the current input were read. The original research-review statement about matching the paper with WHO/ChiCTR is historical; all current external access and reading remain unattempted. Individual access dates/levels are null because the original fields are absent.
Verification status: Met
Materials actually read: The retained Korean/English summaries and case-specific condition/application records were read. External abstracts, full texts, registration, protocols and analysis plans remain unread; access was not attempted.
Why unverified: Actual current local reading, unread external materials and historical statements are separated by physical material type.
Reason for missing information: Individual external access levels/dates and current full-text versions remain unverified.
Required materials and conditions: Material-specific current acquisition/reading, URL, version, historical access date/level and original-location records
Materials to obtain first: Material-specific current acquisition/reading, URL, version, historical access date/level and original-location records
Further research: If external material is actually obtained, verify its own access event, version and original locations and update only the current reading record.
Remaining uncertainty: Individual external access levels/dates and current full-text versions remain unverified. No new difference/CI/denominator/incidence/grade calculation or reassessment.
Conditions for verification: Distinguish actual reading of retained summaries from current unattempted/unread PubMed, DOI, paper, registration and SAP materials; do not inherit access levels/dates from a containing document.
Why this condition is needed: Reading a monotherapy-comparison summary must not be represented as rereading the paper’s full text.
Application exceptions: This condition concerns actual material for the selected comparison. Information from another known comparison, a non-live-birth endpoint or a different product does not substitute for it; no arbitrary sample-size threshold is imposed.
Referenced methods: Existing method principles distinguish population, active treatment, actual exposure, cumulative live birth, follow-up, denominators, analysis, shared controls, funding and harms. Detailed conditions are Chamgap’s own application.

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