Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.

Name: Kaimen Rigor review — Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.
Item: Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.
Rating: 100
Author: Alpha1

Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H

Paper source

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Kaimen Rigor review — 5★ (Exemplary), 0 critical, 0 high issues for “Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.”

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Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Read alongside

Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.

Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H

Read full text (PMC)

DOI

10.1136/bmj-2025-084050

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.

Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H

Paper source

Read full text (PMC)

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Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 15, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and transparently reported randomised controlled trial. The design is rigorous with adequate randomization, sample size justification, and pre-specified analyses. Reporting is exemplary with trial registration, CONSORT flow, and data/code sharing.

Both reviewers classified the study as interventional and agreed on all dimensions. The statistics verification covered only a subset of tests (8 of many); the rest are unverified but no errors were found. The citation check found no retracted or non-existent references.

Numerical inconsistencies

None found

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Checked — nothing surfaced.

Recomputed 8 tests: 8 consistent, 0 inconsistent; 6 recomputed directly from the reported test statistics, 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites retrospective studies suggesting PGT-A benefits in severe male infertility and notes the lack of RCTs. The rationale for the trial is clearly linked to the need for prospective evidence. Limitations of prior research are implicitly addressed by the trial's design.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

“Recent retrospective studies showed that PGT-A was associated with a lower rate of early miscarriage and an increased live birth rate per transfer in couples with severe male factor infertility. However, there are no randomised controlled trials assessing the effect of PGT-A in couples with male factor infertility problems undergoing ICSI.”

Introduction ¶1Find in source

“We performed a multicentre randomised controlled trial in couples with severe male factor infertility undergoing ICSI, and compared the live birth rate after ICSI in couples who had or had not also undergone PGT-A”

Introduction ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

Randomization was computer-generated, stratified by maternal age and BMI, with a 1:1 allocation. The trial is open-label with a clear rationale (nature of interventions). A priori power analysis is provided with effect size, alpha, and power. Inclusion/exclusion criteria are detailed. Outlier handling is addressed through ITT and per-protocol analyses and imputation for missing data. Controls are inherent in the comparator arm. Independent replication is not applicable for a single pivotal trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, sample size calculation, and pre-specified analysis populations.

Evidence

“independent staff performed randomisation stratified by maternal age (20-29.9, 30-34.9, ≥35 years) and body mass index (<18.5, 18.5-24.9, ≥25) using an online system with a computer generated randomisation list.”

MethodsFind in source

“Because of the nature of the interventions, the participants, clinicians, embryologists, and investigators assessing the outcomes were not masked to the group allocation.”

MethodsFind in source

“We determined that a sample size of 436 women (218 per group) would provide a power of 80% to demonstrate or refute this 14% difference at a two sided α level of 0.05, with an estimated dropout rate of 20%.”

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, stratification, and sample size calculation, though open-label and with some missing details on blinding rationale.

Evidence

MethodsFind in source

“Because of the nature of the interventions, the participants, clinicians, embryologists, and investigators assessing the outcomes were not masked to the group allocation.”

MethodsFind in source

Statistical analysisFind in source

Sex is reported (both male and female partners). Age and BMI are reported for both partners. Health status is implied through inclusion/exclusion criteria. Demographics are detailed in Table 1. Species/strain and housing are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial, including sex, age, BMI, and infertility characteristics.

Evidence

paraphrase[Table 1]

“Women (mean (SD) age (years)): 29.9 (3.5) | 30.1 (3.3)”

“Primary infertility | 172 (76.4) | 164 (72.9)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, BMI, and infertility characteristics.

Evidence

paraphrase[Table 1]

“Women (mean (SD) age (years)): 29.9 (3.5) | 30.1 (3.3)”

“Primary infertility | 172 (76.4) | 164 (72.9)”

Table 1Find in source

The study was approved by a named ethics committee with a protocol number. Written informed consent was obtained from all participants. Compliance with Good Clinical Practice and Declaration of Helsinki is stated.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the ethics committee of International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University in China (GKLW2016-16 on 19 October 2016).”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

“The study was performed in accordance with Good Clinical Practice and Declaration of Helsinki principles”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the ethics committee of International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University in China (GKLW2016-16 on 19 October 2016).”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

“The study was performed in accordance with Good Clinical Practice and Declaration of Helsinki principles”

MethodsFind in source

The investigational product is ICSI with PGT-A, and the paper identifies the sequencing platforms and software used. Reagents such as dydrogesterone and progesterone are named with manufacturers. Antibodies, cell lines, and mycoplasma testing are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Key resources, including the investigational product (PGT-A) and software, are adequately identified.

Evidence

“The next generation sequencing platforms used in our study included the Illumina NextSeq 550 or Ion PGM/Proton (Thermo Fisher Scientific, Waltham, MA, USA).”

MethodsFind in source

“All analyses were performed with R software, version 4.0.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Key resources are adequately identified, including the investigational product (ICSI/PGT-A) and software.

Evidence

“The next generation sequencing platforms used in our study included the Illumina NextSeq 550 or Ion PGM/Proton (Thermo Fisher Scientific, Waltham, MA, USA).”

MethodsFind in source

“All analyses were performed with R software, version 4.0.”

Statistical analysisFind in source

“Patients using an artificial regimen were given vaginal progesterone gel at a dose of 90 mg once daily (Crinone, Merck Serono, Germany), or at a dose of 200 mg three times daily (Utrogestan, Belsins, Belgium)”

MethodsFind in source

Statistical tests are named (Wilcoxon rank sum, chi-square, binomial regression, Cox proportional hazards). Assumptions are addressed through non-parametric tests and Schoenfeld residuals. Exact p-values are reported. Effect sizes with 95% CIs are provided. Software is identified. Data presentation includes per-group n and appropriate figures. Mathematical plausibility checks were not performed due to large N and continuous outcomes.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-reported, with exact p-values and effect sizes with CIs.

Evidence

“comparisons between groups were analysed using the Wilcoxon rank sum test because of the non-normality of the variables.”

Statistical analysisFind in source

paraphrase[Abstract, Results]

“P=0.64”

“odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58)”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with CIs.

Evidence

“comparisons between groups were analysed using the Wilcoxon rank sum test because of the non-normality of the variables.”

Statistical analysisFind in source

paraphrase[Abstract]

“P=0.64”

“odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58)”

AbstractFind in source

The data availability statement provides a concrete route: the dataset and code are on Open Science Framework with a URL. Access is governed by a data use agreement, which is appropriate for patient data. Repository deposit and accession numbers are not applicable for identifiable patient data, but the OSF link serves as the repository.

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are available via a public repository with a persistent identifier.

Evidence

“The dataset and code for analysis can be found on Open Science Framework website ( https://osf.io/g5z2q/?view_only=1f5a8947b50d4fbe9b534433a6a51f22 ).”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are available on OSF with a clear access mechanism.

Evidence

“The dataset and code for analysis can be found on Open Science Framework website ( https://osf.io/g5z2q/?view_only=1f5a8947b50d4fbe9b534433a6a51f22 ).”

Data availabilityFind in source

“Access is governed by a data use agreement to ensure appropriate use and privacy protection.”

Data availabilityFind in source

The trial is registered (NCT02941965). A CONSORT diagram is included. All pre-specified outcomes are reported, including negative results. Limitations are discussed. Conclusions are proportional to the evidence. Funding and COI statements are provided.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent with trial registration, CONSORT flow, and comprehensive outcome reporting.

Evidence

“ClinicalTrials.gov NCT02941965”

AbstractFind in source

“Fig 1 Trial profile. CONSORT (consolidated standards of reporting trials) diagram”

Results ¶1Find in source

“However, limitations remain: firstly, male infertility should be diagnosed based on a comprehensive evaluation”

LimitationsFind in source

PASSReviewer 2· 95% conf

Reporting is transparent with trial registration, CONSORT diagram, and comprehensive outcome reporting.

Evidence

“Trial registration ClinicalTrials.gov NCT02941965”

AbstractFind in source

“Fig 1 Trial profile. CONSORT (consolidated standards of reporting trials) diagram”

Results ¶1Find in source

“However, limitations remain: firstly, male infertility should be diagnosed based on a comprehensive evaluation”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 33 references by DOI: 30 verified — 3 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, grammar, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the open-label design and the exploratory subgroup finding in overweight women, but these are adequately discussed. No erratum or re-analysis is warranted based on this audit.

1.
MEDIUMcopyedit
In the Abstract and figure legend, correct the typo 'ISCI' to 'ICSI'.
Consistency in terminology is essential for professional presentation.
2.
MEDIUMcopyedit
In Methods, Randomisation and masking, add the missing word 'consent' to 'written informed'.
Grammar error that could confuse readers.
3.
MEDIUMcopyedit
In Results, paragraph 2, ensure consistent use of 'median number' (singular) or 'median numbers' (plural).
Minor grammatical inconsistency.
4.
MEDIUMcopyedit
In Methods, Statistical analysis, clarify the sentence about sample size re-evaluation for the co-primary endpoint design.
The current phrasing is confusing and could be misinterpreted.
5.
MEDIUMcopyedit
In Results, paragraph 3, rephrase the sentence about couples undergoing two transfer cycles for clarity.
The current sentence is awkward and could be clearer.
6.
LOWreporting
In the Introduction, explicitly acknowledge limitations of prior retrospective studies (e.g., selection bias, lack of control).
Strengthens the scientific premise by addressing limitations of prior work.
7.
LOWreporting
In Methods, provide a brief rationale for the open-label design beyond 'nature of the interventions'.
Addresses potential bias concerns and improves transparency.
8.
LOWreporting
In the Discussion, discuss the generalizability of findings to other populations and settings.
Helps readers interpret the applicability of the results.
9.
LOWdata code
In the Data Availability Statement, clarify the process for requesting data access (e.g., timeline, criteria).
Enhances transparency and usability of the shared data.
10.
LOWreporting
In the Results, report the number of participants with missing data for each outcome.
Improves completeness and allows readers to assess potential bias.
11.
LOWstatistics
In the Statistical Analysis, specify the exact version of R and any packages used.
Improves reproducibility.
12.
LOWreporting
In the Discussion, avoid overemphasizing the subgroup finding in overweight women as it was exploratory and not pre-specified.
Prevents overinterpretation of exploratory analyses.
13.
LOWreporting
In the Methods, provide more detail on the embryo biopsy procedure and quality control measures.
Enhances methodological transparency.
14.
LOWreporting
In the Results, consider presenting the per-protocol analysis results in the main text.
Transparency about sensitivity analyses.
15.
LOWreporting
In the Discussion, discuss the potential impact of the funding limitation (only covering 1-3 embryos) on the results.
Contextualizes a potential source of bias.

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Preimplantation genetic testing for aneuploidy versus no genetic testing in couples undergoing intracytoplasmic sperm injection for severe male infertility: multicentre, open label, randomised controlled trial.

Lin X, Wu D, Zhang C, Wang L, Lu Y, Zhou P, Zhou C, Jin L, Wang L, Zhu H, Pan J, Xu C, Chen S, Gao L, Li L, Zhang S, Wu Y, Sun Y, Mol BW, Huang H

Read full text (PMC)

DOI

10.1136/bmj-2025-084050

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Record fingerprint

cff846938ee405ba84701f9ba24d84478484d266ec8bf978a410ace23dd7d287

Verify via API

Issued Aug 15, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

5 / 5

Exemplary — no material problems found

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — no deductions. Nothing the checks ran surfaced a material problem.

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

01ArithmeticNone found 102OverreachOverstated conclusions 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit6 minor suggestions

Numerical inconsistencies

None found

Checked — nothing surfaced.

Recomputed 8 tests: 8 consistent, 0 inconsistent; 6 recomputed directly from the reported test statistics, 2 via agent-written checks.

Overstated conclusions

1 finding · worst low

Conclusions only partially backed by the presented evidenceAssessed

5 major claims checked against the paper's own evidence: 1 only partially supported (evidence backs part of the claim; gaps or caveats remain); the rest adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

PASSReviewer 2· 90% conf

The paper establishes a clear scientific premise with prior work cited and a logical rationale for the trial.

Evidence

Introduction ¶1Find in source

Introduction ¶2Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous with adequate randomization, sample size calculation, and pre-specified analysis populations.

Evidence

MethodsFind in source

“Because of the nature of the interventions, the participants, clinicians, embryologists, and investigators assessing the outcomes were not masked to the group allocation.”

MethodsFind in source

Statistical analysisFind in source

PASSReviewer 2· 95% conf

The trial design is rigorous with clear randomization, stratification, and sample size calculation, though open-label and with some missing details on blinding rationale.

Evidence

MethodsFind in source

“Because of the nature of the interventions, the participants, clinicians, embryologists, and investigators assessing the outcomes were not masked to the group allocation.”

MethodsFind in source

Statistical analysisFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Biological variables are well reported for a human trial, including sex, age, BMI, and infertility characteristics.

Evidence

paraphrase[Table 1]

“Women (mean (SD) age (years)): 29.9 (3.5) | 30.1 (3.3)”

“Primary infertility | 172 (76.4) | 164 (72.9)”

Table 1Find in source

PASSReviewer 2· 90% conf

Biological variables are well reported for a human trial, including sex, age, BMI, and infertility characteristics.

Evidence

paraphrase[Table 1]

“Women (mean (SD) age (years)): 29.9 (3.5) | 30.1 (3.3)”

“Primary infertility | 172 (76.4) | 164 (72.9)”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the ethics committee of International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University in China (GKLW2016-16 on 19 October 2016).”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

“The study was performed in accordance with Good Clinical Practice and Declaration of Helsinki principles”

MethodsFind in source

PASSReviewer 2· 95% conf

Ethical approval and informed consent are clearly documented.

Evidence

“This study was approved by the ethics committee of International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University in China (GKLW2016-16 on 19 October 2016).”

EthicsFind in source

“All participants provided written informed consent.”

EthicsFind in source

“The study was performed in accordance with Good Clinical Practice and Declaration of Helsinki principles”

MethodsFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 85% conf

Key resources, including the investigational product (PGT-A) and software, are adequately identified.

Evidence

“The next generation sequencing platforms used in our study included the Illumina NextSeq 550 or Ion PGM/Proton (Thermo Fisher Scientific, Waltham, MA, USA).”

MethodsFind in source

“All analyses were performed with R software, version 4.0.”

Statistical analysisFind in source

PASSReviewer 2· 90% conf

Key resources are adequately identified, including the investigational product (ICSI/PGT-A) and software.

Evidence

“The next generation sequencing platforms used in our study included the Illumina NextSeq 550 or Ion PGM/Proton (Thermo Fisher Scientific, Waltham, MA, USA).”

MethodsFind in source

“All analyses were performed with R software, version 4.0.”

Statistical analysisFind in source

MethodsFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical methods are appropriate and well-reported, with exact p-values and effect sizes with CIs.

Evidence

“comparisons between groups were analysed using the Wilcoxon rank sum test because of the non-normality of the variables.”

Statistical analysisFind in source

paraphrase[Abstract, Results]

“P=0.64”

“odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58)”

AbstractFind in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described, with exact p-values and effect sizes with CIs.

Evidence

“comparisons between groups were analysed using the Wilcoxon rank sum test because of the non-normality of the variables.”

Statistical analysisFind in source

paraphrase[Abstract]

“P=0.64”

“odds ratio 1.09 (95% confidence interval (CI) 0.76 to 1.58)”

AbstractFind in source

Sub-criteria

code sharingADEQUATE

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Data and code are available via a public repository with a persistent identifier.

Evidence

“The dataset and code for analysis can be found on Open Science Framework website ( https://osf.io/g5z2q/?view_only=1f5a8947b50d4fbe9b534433a6a51f22 ).”

Data availabilityFind in source

PASSReviewer 2· 95% conf

Data and code are available on OSF with a clear access mechanism.

Evidence

“The dataset and code for analysis can be found on Open Science Framework website ( https://osf.io/g5z2q/?view_only=1f5a8947b50d4fbe9b534433a6a51f22 ).”

Data availabilityFind in source

“Access is governed by a data use agreement to ensure appropriate use and privacy protection.”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineADEQUATE

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The manuscript is transparent with trial registration, CONSORT flow, and comprehensive outcome reporting.

Evidence

“ClinicalTrials.gov NCT02941965”

AbstractFind in source

“Fig 1 Trial profile. CONSORT (consolidated standards of reporting trials) diagram”

Results ¶1Find in source

“However, limitations remain: firstly, male infertility should be diagnosed based on a comprehensive evaluation”

LimitationsFind in source

PASSReviewer 2· 95% conf

Reporting is transparent with trial registration, CONSORT diagram, and comprehensive outcome reporting.

Evidence

“Trial registration ClinicalTrials.gov NCT02941965”

AbstractFind in source

“Fig 1 Trial profile. CONSORT (consolidated standards of reporting trials) diagram”

Results ¶1Find in source

“However, limitations remain: firstly, male infertility should be diagnosed based on a comprehensive evaluation”

LimitationsFind in source

Registered (1 ID: ClinicalTrials.gov). Reporting guideline cited: CONSORT.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 33 references by DOI: 30 verified — 3 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

6 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 6 minor suggestions below.

6 copyedit issues flagged: mostly consistency, grammar, typo.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
MEDIUMcopyedit
In the Abstract and figure legend, correct the typo 'ISCI' to 'ICSI'.
Consistency in terminology is essential for professional presentation.
2.
MEDIUMcopyedit
In Methods, Randomisation and masking, add the missing word 'consent' to 'written informed'.
Grammar error that could confuse readers.
3.
MEDIUMcopyedit
In Results, paragraph 2, ensure consistent use of 'median number' (singular) or 'median numbers' (plural).
Minor grammatical inconsistency.
4.
MEDIUMcopyedit
In Methods, Statistical analysis, clarify the sentence about sample size re-evaluation for the co-primary endpoint design.
The current phrasing is confusing and could be misinterpreted.
5.
MEDIUMcopyedit
In Results, paragraph 3, rephrase the sentence about couples undergoing two transfer cycles for clarity.
The current sentence is awkward and could be clearer.
6.
LOWreporting
In the Introduction, explicitly acknowledge limitations of prior retrospective studies (e.g., selection bias, lack of control).
Strengthens the scientific premise by addressing limitations of prior work.
7.
LOWreporting
In Methods, provide a brief rationale for the open-label design beyond 'nature of the interventions'.
Addresses potential bias concerns and improves transparency.
8.
LOWreporting
In the Discussion, discuss the generalizability of findings to other populations and settings.
Helps readers interpret the applicability of the results.
9.
LOWdata code
In the Data Availability Statement, clarify the process for requesting data access (e.g., timeline, criteria).
Enhances transparency and usability of the shared data.
10.
LOWreporting
In the Results, report the number of participants with missing data for each outcome.
Improves completeness and allows readers to assess potential bias.
11.
LOWstatistics
In the Statistical Analysis, specify the exact version of R and any packages used.
Improves reproducibility.
12.
LOWreporting
In the Discussion, avoid overemphasizing the subgroup finding in overweight women as it was exploratory and not pre-specified.
Prevents overinterpretation of exploratory analyses.
13.
LOWreporting
In the Methods, provide more detail on the embryo biopsy procedure and quality control measures.
Enhances methodological transparency.
14.
LOWreporting
In the Results, consider presenting the per-protocol analysis results in the main text.
Transparency about sensitivity analyses.
15.
LOWreporting
In the Discussion, discuss the potential impact of the funding limitation (only covering 1-3 embryos) on the results.
Contextualizes a potential source of bias.

Full text (55,826 chars)Analyzed: Aug 15, 2026