Safdarian 2011.
Study characteristics | ||
Methods | RCT, 2 arms, 100 randomised Setting: Iran, hospital, one centre Study period: July 2008 to March 2009 (unclear if recruitment period or whole study period) |
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Participants |
Criteria relating to previous IVF failure: no Inclusion criteria: 20 to 39 year‐old infertile women who were referred to the fertility centre Exclusion criteria: women older than 39 years of age; follicle‐stimulating hormone > 11; endometriosis; hypothalamic amenorrhoea; azoospermic male |
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Interventions |
Study group: pipelle procedure on day 21 menstrual cycle preceding IVF cycle, with use of contraceptive pill before IVF‐embryo transfer treatment Control group: no procedure |
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Outcomes | Reported in paper: clinical pregnancy Obtained by author correspondence: ‐ |
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Notes | Trial registration: IRCT201008154572N1 (registered Sep 2011, registered retrospectively) Additional concerns and comments: across an apparent 9‐month recruitment period, trial team recruited 11 women per month ‐ which is a reasonably high rate, however not on its own a serious concern. Funding: this project was financially supported by Infertility Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran. Author correspondence: Emails sent to corresponding author (shmovahedy@razi.tums.ac.ir) but no reply received Publication: full‐text. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Computerised; participants were randomly selected on the basis of agreement to undergo endometrial biopsy expressed in a written informed consent before the start of the IVF cycle. This wording suggests the allocation was based on the participants agreement or preference, 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 | Does not appear to be any attrition |
Selective reporting (reporting bias) | High risk | Trial was registered retrospectively and only reported clinical pregnancy, not live birth or any adverse events. |
Other bias | High risk | Trial registered retrospectively. |