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

Inal 2012.

Study characteristics
Methods RCT, 2 arms, 100 randomised
Setting: academic setting, Turkey
Study period: January 2008‐March 2009 (unclear if recruitment period or entire study period)
Participants Criteria related to previous IVF failure: yes, failed to conceive during 1 or more cycles of IVF and embryo transfer (ET)
Inclusion criteria: women considered to be good responders to hormonal stimulation; age between 25 and 36 years
Exclusion criteria: hydrosalpinx; thrombophilia; submucous myoma and factors found to have a negative impact on implantation
Interventions Study group: 2 consecutive endometrial biopsies at 1‐week intervals during the luteal phase of the non‐transfer cycle, when on Gonadotropin‐releasing hormone agonist for downregulation. Endometrial biopsy was performed with a biopsy catheter (Pipelle de Cornier, Prodimed, Neuilly‐en‐Thelle, France) introduced through the cervical os and rotated within the uterine cavity 3‐4 times after withdrawal of the piston. Antibiotics were administered after the procedure
Control group: no intervention
Outcomes Reported in paper: live birth, clinical pregnancy, miscarriage
Obtained from author correspondence: ‐
Notes Trial registration: believed to be: NCT01340560 (registered Apr 2011, registered retrospectively)
Additional concerns and comments: Implantation and clinical pregnancy rates appear inconsistent; similar implantation rates reported in each arm (31% versus 35%) however clinical pregnancy rates significantly different (34% versus 60%); no obvious explanation.
Funding: quote:"This study has no financial support"
Author correspondence: yes, undertaken
Publication: full‐text.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Paper states quote:"The randomization was based on a computer generated random numbers"
Allocation concealment (selection bias) Unclear risk No description provided
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 Appears to be no attrition
Selective reporting (reporting bias) High risk Unclear if registered, and important outcomes such as adverse events not reported
Other bias High risk Trial registered retrospectively. There is an apparent inconsistency in the implantation and pregnancy rates reported, which are similar per arm for implantation rate but significantly different for clinical pregnancy rates.