Hamza 2016.
Study characteristics | ||
Methods | Randomised controlled trial, 2 groups, setting not described, authors are from Egypt (affiliation: Menoufia University) Study duration: not described Number of participants randomised: unknown Number of participants analysed: 146 |
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Participants | Inclusion and exclusion criteria: not described Cause of infertility: unexplained infertility (described in trial registry) |
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Interventions |
Degree of endometrial injury: pipelle Timing of endometrial injury: in the luteal phase of a spontaneous menstrual cycle (not described on which day) Study length: not described Type of conception: IUI |
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Outcomes | Reported in the abstract:
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Notes | Only a conference abstract was available Funding source: not described Conflicts of interest: not described Trial registration: PACTR201509001264171 (registration date September 2015, start date September 2015). Based on information in the trial registry, the trial was registered prospectively. However, start date is not confirmed by study authors, and actual study duration is not described in the abstract Author correspondence was undertaken, but we did not receive a response |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "randomisation in 1:1 ratio was carried out using computer‐generated simple random tables" |
Allocation concealment (selection bias) | Unclear risk | Not reported in the abstract. Use of "sealed opaque envelopes" was described on the trial registration page. However it remains unclear whether this was the actual method of allocation concealment, and whether these envelopes were sequentially numbered |
Blinding of participants (performance bias) | Unclear risk | Abstract did not report blinding of participants. A sham procedure was performed, but it is unclear whether participants were effectively blinded |
Blinding of personnel (performance bias) | Unclear risk | Abstract did not report any blinding of personnel |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Abstract did not report blinding of outcome assessors, and it was unlikely; however outcomes were unlikely to be influenced by lack of blinding, as there were no patient‐reported outcomes |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Abstract did not report any information about missing data |
Selective reporting (reporting bias) | Unclear risk | All outcomes reported in the abstract were pre‐specified in the trial registry. However, it is unclear whether the trial was truly registered prospectively, as the actual start date of the trial is not confirmed by study authors. Therefore risk of reporting bias is rated as unclear |
Other bias | High risk | Enrolment and follow‐up were completed within 8 months (September 2015 to April 2016) (data from trial registration page). The follow‐up duration was not described, but clinical pregnancy was one of the outcomes of the trial. The last participant probably would have been enrolled in the sixth month. It seems unlikely to us that a study with 146 participants can be completed in such a short period; however it is not impossible |