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. 2021 Jun 10;2021(6):CD009517. doi: 10.1002/14651858.CD009517.pub4

Aflatoonian 2016.

Study characteristics
Methods RCT, 2 arms, 100 randomised
Setting: Iran, research/clinical centre, one centre
Study period: March 2015 to January 2016 (recruitment period unclear)
Participants Criteria related to previous IVF failure: none
Inclusion criteria: women indicated for frozen embryo transfer treatment, had one or more frozen embryo(s) and had a normal uterine cavity (confirmed by vaginal ultrasonography).
Exclusion criteria: <40 years (assume error > 40), history of endocrine disorders (hypothyroidism, diabetes mellitus), intrauterine abnormality (uterine polyp, sub‐mucosal fibroma, intrauterine adhesion) and severe endometriosis diagnosed by laparoscopy or endometrioma in ultrasound scanning.
Interventions Study group: pipelle procedure once between days 21‐23 of the cycle prior to the embryo transfer cycle
Control group: no procedure
Outcomes Reported in paper: ongoing pregnancy, clinical pregnancy, miscarriage, multiple pregnancy
Obtained by author correspondence: ‐
Notes Trial registration: IRCT2015101324512N1 (registered November 2015, retrospective registration)
Additional concerns and comments: recruitment rate was high at approximately 14 patients per month. The first author is also the first author of an RCT which has been retracted for methodological issues, which may have been misrepresented (e.g. not a true RCT) (Aflatoonian 2013). The first author has published a large number of trials as first author recently (total of five RCTs as first author in the last 10 years). Additionally, the implantation rates are not consistent with the clinical pregnancy and multiple pregnancy rates; which raises some concern about how the validity of the results.
Funding: the financial supporter was Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences, Yazd, Iran.
Author correspondence: Attempted, however no response received
Publication: full‐text
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Paper states quote: "a computer‐generated randomization table was created" but also that "93 consecutive subjects" were recruited, therefore unclear whether truly randomised
Allocation concealment (selection bias) Unclear risk No description
Blinding of participants and personnel (performance bias)
All outcomes High risk No blinding employed
Blinding of outcome assessment (detection bias)
All outcomes Low risk Only reporting objective outcomes
Incomplete outcome data (attrition bias)
All outcomes Low risk Appears to be no attrition
Selective reporting (reporting bias) High risk Retrospective trial registration and not reporting live birth or adverse events such as pain/bleeding
Other bias High risk Trial registered retrospectively. Additionally, the implantation rates are not consistent with the clinical pregnancy and multiple pregnancy rates; which raises some concern about how the validity of the results.