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 |
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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 |
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Outcomes | Homocysteine levels Cumulative clinical pregnancy rate over 3 cycles Ongoing pregnancy rate |
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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 |
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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 |