Karimzadeh 2009.
Study characteristics | ||
Methods | RCT, 2 arms, 115 randomised Setting: Iran in an academic setting Recruitment period: Unclear |
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Participants |
Criteria related to previous IVF failure: yes, recurrent implantation failure (defined as 2 to 6 unsuccessful cycles of IVF‐embryo transfer with previous transfer of at least 10 high‐grade embryos without achievement of clinical pregnancy) Inclusion criteria: age between 20 and 40 years; no history of blood disease; Exclusion criteria: age > 40 years; poor response in previous cycles (defined as day 3 follicle‐stimulating hormone > 10 IU mL or < 4 follicles on the day of trigger in previous cycle); uterine malformation; presence of endometrioma; ultrasound evidence of hydrosalpinx |
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Interventions |
Study group: 1 endometrial injury procedure using Pipelle de Cornier on days 21‐26 of spontaneous cycle Control group: no intervention |
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Outcomes | Reported in paper: clinical pregnancy Obtained by author correspondence: ‐ |
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Notes | Trial registration: does not appear to be registered Additional concerns and comments: one of the authors is an author on a paper which has been retracted for duplication, as it was very similar to another paper by the same author group in a different journal (Mohsenzadeh 2018). Funding: Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences. 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 | Quote: "Random selection to either group was performed by drawing a piece of paper from the bag containing equal number of printed paper for each method" |
Allocation concealment (selection bias) | High risk | No description of any safeguards in place to ensure allocation concealment and prevent someone from replacing the paper and selecting another |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding was employed |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Only objective outcomes reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Nine women lost to follow‐up in each arm (4 and 5) |
Selective reporting (reporting bias) | High risk | Trial does not appear to have been registered and important outcomes such as live birth and adverse events not reported |
Other bias | High risk | Trial not registered. Authors are also co‐authors of a retracted paper. |