Siebert 2009.
Methods | RCT Setting: South Africa Method of randomisation: computer‐generated random numbers Blinding: unblinded Number randomised: 107 |
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Participants | Summary: metformin and CC vs CC in obese PCOS women Inclusion criteria: PCOS (according to Rotterdam consensus 2003), confirmed tubal patency Exclusion criteria: male factor subfertility Baseline characteristics of each group: metformin and CC (n = 42) vs CC (n = 48)
Dropouts: 17, 10 in metformin + CC group and 7 in CC‐only group |
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Interventions | Main intervention: metformin 850 mg twice daily Duration: 6 weeks before and throughout ovulation induction with CC Co‐interventions: CC 50‐150 mg day 4‐8 for 4 cycles |
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Outcomes | Primary: none Secondary: ovulation: day‐21 progesterone level (level not stated) |
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Notes | A single‐centre RCT investigated the benefit of using metformin in CC ovulation induction treatment. ITT was used in our analysis. Participant lost to follow‐up classified as non‐responder; whilst pregnant participants did not attend follow‐up visit (1 in each arm) were classified as responder No units for insulin, glucose and testosterone in the paper |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Unblinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Unblinded |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts: no significant difference in the dropout rates, 10 in metformin + CC group and 7 in CC‐only group; no reason for dropout |
Selective reporting (reporting bias) | Unclear risk | Insufficient information in the study |
Other bias | Low risk | No evidence of other bias |