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Single oral dose of vitamin D3 supplementation prior to in vitro fertilization and embryo transfer in normal weight women: the SUNDRO randomized controlled trial

Assessed by RV013 · Clinical Chair in Health Services Research

Assessed on 2 Mar 2026

OverallReviewer's overall integrity assessment, derived from all research questions Serious concerns

DOI 10.1016/j.ajog.2021.04.234 (opens in new tab)

Resource ripekg:research-integrity-assessment/RIPEA212731D631747726

5 Research Questions · 7 Evidence Items

Q1.1 — Does the study have an associated retraction?

Automated Assessment:Assessment produced by the automated systemNo
Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No retraction found

Q1.2 — Does the study have an associated expression of concern or other relevant post-publication notice?

Automated Assessment:Assessment produced by the automated systemNo
Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: No rationale provided

Q1.3 — Do other studies by the research team highlight causes for concern?

Automated Assessment:Assessment produced by the automated systemYes
Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsYes

Rationale: Multiple concerns

Supporting Evidence (5)

Retraction NoticeSource: Retraction Watch database

Attractiveness of women with rectovaginal endometriosis: a case-control study

10.1016/j.fertnstert.2020.09.001 (opens in new tab)
Journal: Fertility and SterilityPublisher: ElsevierDate: 13 Sept 2020

RetractionWatch ID:Record identifier in the Retraction Watch database 24180

Rationale: Objections by Third Party

About Author: Edgardo Somigliana

Retraction NoticeSource: Retraction Watch database

Randomized, double blind placebo-controlled trial: effects of Myo-inositol on ovarian function and metabolic factors in women with PCOS

10.26355/eurrev_202309_33752 (opens in new tab)
Journal: European Review for Medical and Pharmacological SciencesPublisher: Verduci EditoreDate: 15 Sept 2023

RetractionWatch ID:Record identifier in the Retraction Watch database 47831

Rationale: Concerns/Issues About Authorship/Affiliation;Duplication of/in Article;Investigation by Third Party;Lack of Approval from Author

About Author: Enrico Papaleo

Retraction NoticeSource: Retraction Watch database

Psychological assessment of the effects of treatment with phytoestrogens on postmenopausal women: a randomized, double-blind, crossover, placebo-controlled study

10.1016/j.fertnstert.2024.12.003 (opens in new tab)
Journal: Fertility and SterilityPublisher: ElsevierDate: 27 Dec 2024

RetractionWatch ID:Record identifier in the Retraction Watch database 60883

Rationale: Concerns/Issues About Data;Duplication of Data;Euphemisms for Duplication;Investigation by Journal/Publisher;Investigation by Third Party

About Author: Enrico Papaleo

Q2.2 — Are there concerns relating to the timing or absence of study registration?

Automated Assessment:Assessment produced by the automated systemUnclear
Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsNo

Rationale: Eudract number registered 2015

Supporting Evidence (2)

Clinical Trial RegistrationSource: Clinical trial registry (e.g. ClinicalTrials.gov, ISRCTN)

Registration ID: 2015-004233-27

Registry: EU CTR

Registry Link: https://trialsearch.who.int/Trial2.aspx?TrialID=2015-004233-27 (opens in new tab)

Prospective:Whether the trial was registered before participant recruitment began No

Assessment Rationale:How INSPECT-AI determined the prospective registration status by comparing dates Registry registration date (study_first_submit_qc_date) is missing or empty.

Study Design EvidenceDates and timelines extracted by INSPECT-AI from the publication text

Recruitment Start: 10-10-2016

Recruitment Start Rationale:INSPECT-AI's reasoning for how it identified the recruitment start date Materials and Methods: 'the date of initial participant enrollment was October 10, 2016.'

Recruitment End: 01-2019

Recruitment End Rationale:INSPECT-AI's reasoning for how it identified the recruitment end date Materials and Methods: 'Women undergoing IVF... between October 2016 and January 2019 were considered for study entry.' This indicates that recruitment finished in January 2019.

Study End: 08-2020

Study End Rationale:INSPECT-AI's reasoning for how it identified the study end date Outcome measures: 'Recruitment was stopped once the scheduled sample size was reached. Follow-up was prolonged up to the end of August 2020.'

Overall — What is the overall integrity assessment of the study?

Automated Assessment:Assessment produced by the automated systemN/A
Human Assessment:Assessment by a domain expert reviewer, informed by AI resultsSerious concerns

Rationale: Previous retractions for two authors.