Fatima 2018.
Methods | RCT Setting: Pakistan Method of randomisation: consecutive non‐probability sampling Blinding: unclear Number randomised: 128 |
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Participants | Summary: metformin and CC versus CC alone Inclusion criteria: PCOS ‐ unclear how diagnosed; duration of fertility ≤ 3 years, age 20‐35 years Exclusion criteria: use of oral contraceptives, comorbid medical conditions, those not living with their husband Baseline characteristics of each group: metformin and CC (n = 64) vs CC (n = 64)
Dropouts: none |
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Interventions | Main intervention: metformin 500 mg 3/d Duration: 3 cycles Co‐interventions: CC 50 mg from day 2 until day 6 of cycle, increased to 100 mg then 150 mg for 3 consecutive cycles |
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Outcomes | Primary: none Secondary: clinical pregnancy: urine pregnancy test and confirmed on US |
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Notes | Endocrine and metabolic factors not measured, including BMI | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Consecutive non‐probability sampling |
Allocation concealment (selection bias) | High risk | Consecutive sampling |
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 | The primary outcome, clinical pregnancy, was clearly reported. |
Other bias | Low risk | No evidence of other bias |