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

Raja 2005.

Methods RCT
Setting: Pakistan
Method of randomisation: unclear
Blinding: single‐blinded (ultrasonographers were blinded)
Number randomised: 100
Participants Summary: metformin and CC vs CC alone
Inclusion criteria: PCOS (diagnosed by presence of PCO on ultrasound and ≥ 2 of oligomenorrhoea, hirsutism, hyperandrogenism, elevated LH or LH:FSH ratio). Tubal patency and normal semen analysis
Exclusion criteria: other endocrine disorders including congenital adrenal hyperplasia, Cushing's syndrome, hyperprolactinaemia and thyroid disease
Baseline characteristics of each group: metformin and CC vs CC alone
  • Mean age (SD) 26.52 (2.3) vs 26.88 (2.4)

  • Normal menstrual cycle (number) 32 (64%) vs 28 (56%)

  • Mean testosterone levels


Dropouts: none
Interventions Main intervention: metformin 500 mg 3/d
Duration: 6 cycles
Co‐interventions: CC 50 mg from day 2 until day 6 of cycle
Outcomes Primary: gastrointestinal side effects
Secondary: clinical pregnancy rate, ovulation: follicle tracking on transvaginal US and day 21 progesterone > 8 mg/mL, adverse effects: teratogenic effects
Notes Old paper ‐ unable to read baseline testosterone levels
No information on method of randomisation
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No method of randomisation
Allocation concealment (selection bias) Unclear risk No information available
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk No information available
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk No information available
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No dropouts
Selective reporting (reporting bias) Unclear risk Insufficient information in the study
Other bias Low risk No evidence of other bias, however, reporting of methodology limited