Zakherah 2010.
Methods | Randomised trial conducted in Egypt Timing: January 2007 to February 2009 |
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Participants | 150 women with clomiphene‐resistant PCOS attending an infertility clinic. Mean age for CC + tamoxifen group 25.6 ± 3.5 years, LOD group 25.6 ± 4.1 years Inclusion: Age between 18 and 38 years, at least 2 years of primary or secondary infertility due to anovulation, patent fallopian tubes on hysterosalpingography or diagnostic laparoscopy, no hormonal treatment in previous 3 months and normal semen values |
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Interventions | CC (150 mg) + tamoxifen (40 mg) from day 3 to day 7 for a maximum of 6 consecutive cycles (n = 75), versus LOD performed through triple‐puncture laparoscopy (4 to 6 puncture points were made through the ovarian capsule of each ovary) (n = 75) Follow‐up for 6 months |
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Outcomes | Pregnancy (biochemical, clinical, live birth), miscarriage, endometrial thickness, ovulation rate (follicles ≥ 18 mm) | |
Notes | No conflicts of interest Clinical trial registration number: not stated |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "Using a computer generated random number table.." |
Allocation concealment (selection bias) | Unclear risk | Quote: "sealed envelopes" Comment: Not clear if opaque and serially numbered |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No details provided but unlikely that there was blinding |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | There was no loss to follow‐up and all 150 women were analysed |
Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. All a priori outcomes in paper were reported |
Other bias | Low risk | No evidence of other risk of bias |