Methods | Prospective randomised placebo‐controlled pilot trial | |
Participants | Infertile Iranian women with PCOS, aged from 25 ‐ 35 years, undergoing ICSI treatment (N = 80) Inclusion criteria: Women who met the Rotterdam criteria for PCOS Exclusion criteria: Hypersensitivity to either MET (metformin) or NAC, infertility factors other than anovulation, male infertility, pelvic organic pathologies, congenital adrenal hyperplasia, thyroid dysfunction, Cushing’s syndrome, hyperprolactinaemia, androgen‐secreting neoplasia, diabetes mellitus, consumption of medications affecting carbohydrate metabolism and hormonal analogues other than progesterone 2 months prior to enrolment in the study and severe hepatic or kidney disease |
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Interventions | 4 groups (n = 20 in each, 5 dropouts from each) 1. Placebo oral rehydration salts; 3 times a day 2. Metformin 500 mg: 1 tablet 3 times a day 3. NAC 600 mg: 1 tablet 3 times a day 4. Metformin 500 mg: 1 tablet 3 times a day + NAC 600 mg: 1 tablet 3 times a day All treatments were administered for 6 weeks |
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Outcomes | Oocyte and embryo quality Endocrine parameters Clinical pregnancy Side effects |
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Notes | Iran, study ran from July 2012 to February 2013 Need to clarify primary and secondary outcomes Author emailed regarding RoB, live birth and miscarriage information; no reply Funded by institutional grant |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | State "random" but method not described |
Allocation concealment (selection bias) | Unclear risk | Not stated |
Blinding (performance bias and detection bias) All outcomes | High risk | Double‐blinded placebo‐controlled, but the placebo group received oral rehydration salts, which are usually in solution, while the treatments were tablets |
Incomplete outcome data (attrition bias) All outcomes | High risk | Dropouts accounted for, but > 25% dropout |
Selective reporting (reporting bias) | Low risk | Outcomes reported |
Other bias | Low risk | No other bias found |