Polanski 2015.
Study characteristics | ||
Methods | RCT, 2 arms, 160 randomised Setting: UK, Nurture Fertility, one centre Recruitment period: January 2013 to July 2014 |
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Participants |
Criteria related to previous IVF failure: no Inclusion criteria: women younger than 49 years with history of primary or secondary infertility undergoing fresh IVF/ICSI treatment or frozen embryo replacement cycle Exclusion criteria: non‐ovulatory cycle; absent uterus; uterine instrumentation within previous 3 menstrual cycles; women in the oocyte donation programme |
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Interventions |
Study group: endometrial biopsy procedure using Pipelle endometrial sampler (Pipelle de Cornier, Laboratoire CCD, Paris, France) or Wallace/Wallach endometrial sampler as an alternative device; ultrasound performed before the procedure. Procedure performed on cycle day luteinizing hormone (LH) +7 to LH+9 of the cycle directly preceding commencement of down‐regulation before IVF or ICSI treatment Control group: no intervention |
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Outcomes | Reported in paper: Clinical pregnancy, miscarriage Obtained by author correspondence: live birth, multiple pregnancy, pain (binary), bleeding |
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Notes | Trial registration: NCT01882842 (registered Jun 2013, registered 5 months retrospectively) Additional concerns and comments: none Funding: the University of Nottingham and Nurture Fertility through local research funds. Author correspondence: yes, undertaken with Nick.Raine‐Fenning@nurturefertility.co.uk and lucas.polanski@hotmail.com This trial was included in the previous version of this review with ongoing/interim data (Polanski 2014). The study is now finished, and was presented at a conference in 2015 but has not yet been published in full; further details and outcomes were provided by author correspondence. Publication: abstract only (and authors provided a full‐text manuscript, which has not been published). |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote:"computer generated random code using random permuted blocks of randomly varying size was used to allocate participants" from author correspondence |
Allocation concealment (selection bias) | Low risk | Patient details were entered into an online randomisation tool, author correspondence confirmed randomisation only revealed after entering the participants details into the computer program |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding was used |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome of pain during the procedure and bleeding were self‐reported by participants who were not blind to their treatment allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The authors informed us that six women in intervention arm and four in control arm excluded either because withdrew from trial or did not attend for treatment, small numbers ‐ these are only small numbers. |
Selective reporting (reporting bias) | Low risk | Registered approximately 6 months into recruitment, however all important outcomes including live birth reported. |
Other bias | Low risk | The paper is described as a pilot study. Despite a formal power calculation requiring 766 women the study recruited only 160 women due to available timeframe (18 months) and a recruitment rate of 50%. Additionally, the results are only available as an abstract. The authors provided a manuscript for this paper however it has not been published in full. The study was registered late by 5 months. These concerns were not deemed sufficient to constitute a high risk of other bias. |