Rigor Reviewed

Rigor-Reviewed Manuscript

IVF versus ICSI in patients without severe male factor infertility: a randomized clinical trial.

Name: Αlpha¹ Rigor Record — IVF versus ICSI in patients without severe male factor infertility: a randomized clinical trial.
Item: IVF versus ICSI in patients without severe male factor infertility: a randomized clinical trial.
Rating: 39
Author: Αlpha¹

Berntsen S, Zedeler A, Nøhr B, Rønn Petersen M, Grøndahl ML, Andersen LF, Løssl K, Løkkegaard E, Englund AL, Vestergaard Gabrielsen A, Prætorius L, Behrendt-Møller I, Langhoff Thuesen L, Vomstein K, Petri Lauritsen M, Ivanoska Trajcevski A, Frøding Skipper D, Westergaard D, Pinborg A, Svarre Nielsen H, la Cour Freiesleben N

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Αlpha¹ Rigor Review — 1★ (Critical), 2 critical, 3 high issues for “IVF versus ICSI in patients without severe male factor infertility: a randomized clinical trial.”

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Αlpha¹ Editorial

This rigor review was examined and confirmed by Αlpha¹ Editorial · August 15, 2026

Αlpha¹ Rigor Review

Rigor Reviewed

1 / 5

Critical — a demonstrable failure

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

StatisticsImpossible or misreported statistic ×2−2★
IntegrityIntegrity concern ×2−1★
CitationsCitations & links (capped) ×8−1★
StatisticsPrinted percentage does not match its own count (capped) ×4−0.25★

Citations & links are capped at −1★ combined, however many are flagged.

A demonstrable critical failure caps the rating at the minimum, regardless of the deductions above.

Model-reported confidence: moderateReviewer agreement: lowEngine: 7.39.0Source: full text

Problems surfaced5 types

Numerical inconsistencies3

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.

Summary statistic impossible for the stated N (GRIM/GRIMMER)Recomputed
Printed percentage does not match its own countRecomputed
Internal contradictions in the reported numbersAssessed

Overstated conclusions1

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

Broken references and links1

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.

References not resolvable to a published paperRecomputed

This Αlpha¹ Rigor Review uses AI 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.

Critical findings

• PERCENT: 68.5% does not match the reported count 242/414
• PERCENT: 2.9% does not match the reported count 3/179

This is a well-conducted multicenter RCT comparing ICSI versus c-IVF, with strong ethical approvals, detailed biological variable reporting, and a concrete data availability statement. The main weaknesses are the open-label design, lack of explicit CONSORT reporting, and some statistical inconsistencies that could not be fully verified.

All three reviewers agreed on study type (interventional). The synthesis weighed the reviewers' divergent ratings, with specific evidence from the statistics verification component (6/9 inconsistent recomputations) and copyedit issues (denominator errors) influencing the final statuses. N/A dimensions were excluded from scoring.

7 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.

Recomputed 3 tests: 3 consistent, 0 inconsistent; 3 via agent-written checks. 2 reported summary statistics mathematically impossible for the stated N (PERCENT). 4 printed percentages that do not match their own count.

2 integrity concerns flagged (0 high).

Reporting

Eight Dimensions8 pass

The introduction cites prior retrospective studies and two Asian RCTs, acknowledges the debate and lack of evidence for ICSI in non-male factor infertility, and clearly links the premise to the study's objective of comparing CLBR. Limitations of prior work (e.g., retrospective designs, use of cleavage-stage transfers) are addressed in the discussion.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (3) — the votes behind the verdict

WARNReviewer 1· 80% conf

The premise is well established with extensive citation of prior work, but the paper does not explicitly acknowledge weaknesses or limitations of the cited prior studies.

Evidence

paraphrase[Introduction, paragraph 2]

“Paraphrase: Recently, two randomized controlled trials (RCTs) conducted in Asia found no improvement in live birth rate after the first embryo transfer when comparing ICSI with c-IVF among couples with normal sperm parameters and those with nonsevere male factor infertility, respectively.”

direct quote[Introduction, paragraph 3]

“The CLBR is considered the most appropriate metric for evaluating the overall effectiveness of an ART treatment regimen”