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) |
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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. |
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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: ‐ |
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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 The first author is also the first author of an RCT which has been retracted for methodological issues, which may have been misrepresented (e.g. not a true RCT) (Aflatoonian 2013).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 |
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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. |