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. 2021 Mar 18;2021(3):CD011424. doi: 10.1002/14651858.CD011424.pub3

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
Participants Inclusion and exclusion criteria: not described
Cause of infertility: unexplained infertility (described in trial registry)
Interventions
  • Intervention group: endometrial scratching by pipelle for 1 minute in the luteal phase (described in trial registry); it is unknown whether scratching was performed in the same cycle as intrauterine insemination (IUI) or in the cycle preceding IUI

  • Control group: "sham procedure by pressure on the cervix by piece of gauze" (described in the trial registry)


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
Outcomes Reported in the abstract:
  • Clinical pregnancy (not defined)

  • Multiple pregnancy

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
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