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

Fatima 2018.

Methods RCT
Setting: Pakistan
Method of randomisation: consecutive non‐probability sampling
Blinding: unclear
Number randomised: 128
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)
  • mean age (SD) 28.55 (2.39), 28.67 (2.6)


Dropouts: none
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
Outcomes Primary: none
Secondary: clinical pregnancy: urine pregnancy test and confirmed on US
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