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. 2019 Dec 17;2019(12):CD013505. doi: 10.1002/14651858.CD013505

Siebert 2009.

Methods RCT 
Setting: South Africa 
Method of randomisation: computer‐generated random numbers
Blinding: unblinded 
Number randomised: 107
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)
  • median  BMI: 30.48, 30.71

  • median fasting insulin mIU/L: 17.20, 13.6

  • median fasting glucose 5.00, 5,10

  • median total testosterone nmol/L: 2.35, 2.00


Dropouts: 17, 10 in metformin + CC group and 7 in CC‐only group
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
Outcomes Primary: none
Secondary: ovulation: day‐21 progesterone level (level not stated)
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
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