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. 2017 Jul 28;2017(7):CD007807. doi: 10.1002/14651858.CD007807.pub3
Methods Randomised trial
Participants Infertile women diagnosed with insulin‐resistant PCOS (n = 102)
18 women were scheduled for ovulation induction and 84 for IVF/ICSI
Mean age: 28.8 ± 0.4 years
Interventions 1. Folic acid 0.4 mg a day (n = 23)
2. Metformin 1700 mg a day (2 divided doses of 850 mg tablets) + folic acid 0.4 mg: 1 tablet a day (n = 28)
3. Vitamin B complex (50 mg B6, 400 ug folic acid, 500 ug B12, 1 g trimethylglycine and 6 mg pyridoxal‐5‐phosphate): 1 tablet a day (n = 24)
4. Metformin 1700 mg a day (2 divided doses of 850 mg tablets) + vitamin B complex: 1 tablet a day (n = 27)
Women were recruited over 14 months and outcomes were measured over 3 cycles
All groups were given folic acid
Outcomes Homocysteine levels
Cumulative clinical pregnancy rate over 3 cycles
Ongoing pregnancy rate
Notes Israel Tel Aviv, study dates not reported
Dr Morey Schachter ivfdoc@asaf.health.gov.il. Email sent 8th December 2015, no reply
Laboratory costs were partially funded by a company producing vitamins and supplements
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "These 102 patients were randomized before treatment, and after giving informed consent, assigned to one of four groups by opening sealed envelopes containing computer generated random assignation numbers"
Allocation concealment (selection bias) Low risk Sealed envelopes containing computer‐generated random assignation numbers"
Blinding (performance bias and detection bias) All outcomes Unclear risk Unknown
Incomplete outcome data (attrition bias) All outcomes Low risk No attrition
Selective reporting (reporting bias) Low risk No known selective reporting
Other bias Low risk No other bias found