Skip to main content
. 2019 Dec 17;2019(12):CD013505. doi: 10.1002/14651858.CD013505

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)
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)
  • Mean age (SD) 29 (4) vs 27 (5)

  • Mean BMI (SD) 34.1 (7.9) vs 30.2 (4.6)

  • Mean glucose, mg/dL (SD) 93.2 (11.8) vs 85.1 (12.2)

  • Mean insulin levels, mU/mL (SD) 28.5 (6.8) vs 12.1 (5.4


Dropouts: none
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
Outcomes Primary: none
Secondary: clinical pregnancy rate, ovulation: midluteal progesterone > 10 ng/mL, BMI, fasting insulin, testosterone
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