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. 2021 Jun 10;2021(6):CD009517. doi: 10.1002/14651858.CD009517.pub4

Karimzadeh 2009.

Study characteristics
Methods RCT, 2 arms, 115 randomised
Setting: Iran in an academic setting
Recruitment period: Unclear
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
Interventions Study group: 1 endometrial injury procedure using Pipelle de Cornier on days 21‐26 of spontaneous cycle
Control group: no intervention
Outcomes Reported in paper: clinical pregnancy
Obtained by author correspondence: ‐
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Additional concerns and comments: one of the authors is an author on a paper which has been retracted for duplication, as it was very similar to another paper by the same author group in a different journal (Mohsenzadeh 2018).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.
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.