Sherif 2018.
Study characteristics | ||
Methods | RCT, 2 arms, 60 randomised Setting: Ain‐Shams University Hospital, Egypt ‐ one centre Recruitment period: no description |
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Participants |
Criteria related to previous IVF failure: yes, women with previous failed ICSI were excluded Inclusion criteria :age between 25 and 30 years old, BMI between 20 and 30, Cause of infertility either tubal causes, ovulatory causes, unexplained causes Exclusion criteria: endometriotic patients, Male factor of infertility, Uterine cavity abnormalities, previous failed ICSI, hydrosalpinx and pyosalpinx. |
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Interventions | Study group: single induced injury was done on the posterior endometrium 1 cm to 2 cm from the fundus by using modified Cook catheter, on day 6 of the ICSI cycle Control group: no procedure | |
Outcomes | Reported in paper: clinical pregnancy Obtained by author correspondence: ‐ |
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Notes | Trial registration: PACTR201701001968212 (recruitment period unclear however stated to be conducted between 2015‐2017 on trial registry, therefore unclear whether registration was prospective or not but likely retrospective) Additional concerns and comments: none Funding: No description Author correspondence: attempted but no reply received (ahmedsherif@med.asu.edu.eg) Publication: full‐text. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Randomization was achieved by a computer generated randomization table (Research Randomizer Version 4.0 software)". |
Allocation concealment (selection bias) | Unclear risk | No description (trial registration says opaque envelopes used, however this is not described in the paper) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding 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) | Unclear risk | All outcomes from trial registration page are reported, but unclear whether registration was prospective |
Other bias | High risk | Trial does not appear to have been registered prospectively. There was a significant difference in fertilisation rate in favour of the interventional group 83 (63–100) versus 67 (47–83) in the control group (P = 0.020), which would create bias in favour of the intervention arm. |