Mak 2017.
Study characteristics | ||
Methods | RCT, 2 arms, 229 randomised Setting: Hong‐Kong, research/academic institution, one centre Study period: March 2013 to April 2016 (unclear if recruitment period or whole study period) |
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Participants |
Criteria related to previous IVF failure :no Inclusion criteria: scheduled for frozen embryo transfer (FET) cycles using non‐donor oocytes, normal ovulation and were deemed suitable for natural‐cycle FET Exclusion criteria: any uterine anomaly or pathology such as endometrial polyps, endometriomas larger than 4 cm or hydrosalpinx. |
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Interventions | Study group: pipelle procedure performed once in the mid‐luteal phase of the cycle preceding the embryo transfer cycleControl group: endocervical manipulation with pipelle, performed once in the mid‐luteal phase of the cycle preceding the embryo transfer cycle | |
Outcomes | Reported in paper: live birth/ongoing pregnancy, clinical pregnancy, miscarriage, multiple pregnancy Obtained by author correspondence: ‐ |
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Notes | Trial registration: ChiCTRTRC‐12002389 (registered Aug 2012, registered prospectively) Additional concerns and comments: None Funding: None stated Author correspondence: minimal correspondence with jennifermak@cuhk.edu.hk Publication: full‐text. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"computer generated random numbers" |
Allocation concealment (selection bias) | Unclear risk | The random numbers were quote:"concealed in opaque envelopes" unclear if SNOSE |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Sham procedure used. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only reporting objective outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 8/115 and 5/114 women withdrew from the trial (small numbers) |
Selective reporting (reporting bias) | Low risk | Registered prospectively and all outcomes reported |
Other bias | Low risk | ‐ |