Refaie 2005.
Methods | RCT Setting: Egypt Method of randomisation: unclear Blinding: unclear Number randomised: 55 total (34 in group 1 randomised to metformin and CC vs CC alone) |
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Participants | Summary: Group 1 (insulin‐resistant): metformin and CC versus CC alone; Group 2 (non‐insulin‐resistant): CC alone Inclusion criteria: PCOS (Rotterdam criteria) Exclusion criteria: male factor infertility, tubal and peritoneal factors Baseline characteristics of each group: Group 1 (insulin‐resistant) vs group 2 (non‐insulin‐resistant)
Dropouts: none |
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Interventions | Main intervention: metformin 1500 mg/d Duration: 6 months or until pregnancy occurred Co‐interventions: CC 50 mg from day 2 until day 6 of cycle, increased up to 150 mg/d if no evidence of ovulation |
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Outcomes | Primary: none Secondary: clinical pregnancy rate, ovulation: midluteal progesterone > 10 ng/mL, BMI, fasting insulin, testosterone |
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Notes | Unable to distinguish baseline characteristics within group 1 | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Inadequate information |
Allocation concealment (selection bias) | Unclear risk | Inadequate information |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Inadequate information |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Inadequate information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Low risk | All outcomes were reported |
Other bias | Unclear risk | Group 1 was randomised to receive metformin and CC vs CC but there are no baseline characteristics available within these randomised groups |