Raja 2005.
Methods | RCT Setting: Pakistan Method of randomisation: unclear Blinding: single‐blinded (ultrasonographers were blinded) Number randomised: 100 |
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Participants | Summary: metformin and CC vs CC alone Inclusion criteria: PCOS (diagnosed by presence of PCO on ultrasound and ≥ 2 of oligomenorrhoea, hirsutism, hyperandrogenism, elevated LH or LH:FSH ratio). Tubal patency and normal semen analysis Exclusion criteria: other endocrine disorders including congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinaemia and thyroid disease Baseline characteristics of each group: metformin and CC vs CC alone
Dropouts: none |
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Interventions | Main intervention: metformin 500 mg 3/d Duration: 6 cycles Co‐interventions: CC 50 mg from day 2 until day 6 of cycle |
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Outcomes | Primary: gastrointestinal side effects Secondary: clinical pregnancy rate, ovulation: follicle tracking on transvaginal US and day 21 progesterone > 8 mg/mL, adverse effects: teratogenic effects |
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Notes | Old paper ‐ unable to read baseline testosterone levels No information on method of randomisation |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No method of randomisation |
Allocation concealment (selection bias) | Unclear risk | No information available |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No information available |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No information available |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
Selective reporting (reporting bias) | Unclear risk | Insufficient information in the study |
Other bias | Low risk | No evidence of other bias, however, reporting of methodology limited |