Baum 2012.
Study characteristics | ||
Methods | RCT, 2 arms, 36 randomised Setting: Israel, academic research clinic, one centre Recruitment period: July 2006‐June 2009 |
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Participants |
Criteria relating to previous IVF failure: yes, diagnosis of RIF (3 or more unsuccessful cycles of IVF‐ET with good ovarian response in previous cycles) Inclusion criteria: age 18‐41; scheduled for IVF with fresh embryo transfer on the next cycle Exclusion criteria: uterine malformation; presence of endometrioma; ultrasound evidence of hydrosalpinx |
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Interventions |
Study group: pipelle procedure undertaken twice, on days 9–12 and 21–24 of the spontaneous menstrual cycle preceding the IVF treatment cycle Control group: cervical pipelle was done by introducing the biopsy catheter into the cervix without scraping or taking a biopsy specimen, on the same days as above |
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Outcomes | Reported in paper: live birth, clinical pregnancy, miscarriage Obtained by author correspondence: ‐ |
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Notes | Trial registration: NCT00411021 (registered Dec 2006, retrospective registration however was initiated post 2010) Additional concerns and comments: none Funding: none stated Author correspondence: attempted but no response received Publication: full‐text |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomisation was performed quote:"using a table of random numbers" |
Allocation concealment (selection bias) | Unclear risk | No description |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were blinded by use of a cervical pipelle procedure. |
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 | Trial was registered 6 months into recruitment, however no outcomes listed. Live birth reported, however adverse events such as pain not reported. |
Other bias | High risk | On the trial registration page the study authors planned to include 70 women in a cross‐over trial; however in the published study, only 36 women were included and only 1 phase of the study was described. Reasons for the early stop are not stated. Additionally, the trial was registered late. |