Nastri 2013.
| Study characteristics | ||
| Methods | RCT, 2 arms, 158 randomised Setting: Brazil, academic research centre, one centre Recruitment period: June 2010 to March 2012 |
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| Participants |
Criteria relating to previous IVF failure: no Inclusion criteria: all women undergoing ART with planned fresh embryo transfer aged < 38 years Exclusion criteria: ‐ |
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| Interventions |
Study group: pipelle procedure performed once 7 to 14 days before the start of ovarian stimulation Control group: sham procedure performed at the same time. This procedure comprised drying of the cervix with no insertion of any instrument into the cervix or womb |
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| Outcomes | Reported in paper: live birth, clinical pregnancy, miscarriage, multiple pregnancy, pain, bleeding Obtained by author correspondence: ‐ |
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| Notes | Trial registration: NCT01132144 (registered May 2010, registered prospectively) Additional concerns and comments: none Funding: this study was funded by two Brazilian official government research foundations: CNPq (direct funding (process number 473475/2010‐3) and research scholarship) and CAPES (PhD scholarship). Author correspondence: yes, two of the authors are authors on this review (CO, WPM) Publication: full‐text. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Paper states quote:"computer generated random sequence of numbers in blocks of 30 (each block having 15 numbers assigned to intervention and 15 to control" |
| Allocation concealment (selection bias) | Low risk | Paper states quote:"The allocation was sealed in consecutively numbered opaque envelopes and an envelope was assigned as the participant entered the study; however, sealed envelopes were only opened just before the procedure, to ensure allocation concealment" |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Sham procedure employed |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Sham procedure implemented therefore outcome assessors were blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no attrition or loss to follow‐up |
| Selective reporting (reporting bias) | Low risk | Trial was registered prospectively and all outcomes reported |
| Other bias | High risk | The trial was terminated early for a positive effect |