Methods | Randomised double‐blind placebo‐controlled trial | |
Participants | Infertile women with PCOS 18 ‐ 40 years old (n = 64) Mean age: 25.1 ± 4.5 vs 25.4 ± 4.9 years, P = 0.85 Inclusion criteria: age between 18 and 40 years with PCOS according to Rotterdam criteria Exclusion criteria: elevated levels of prolactin, thyroid disorder, or Type 2 diabetes and congenital adrenal hyperplasia. In addition, all PCOS women had normal baseline renal function tests, bilirubin, and aminotransferases |
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Interventions | 1. Selenium 200 ug: 1 tablet a day + metformin 500 mg: which was elevated in a stepwise manner during the first 3 weeks to incorporate the side effects until the participants were taking a total of 1500 mg a day (n = 32) 2. Placebo plus metformin: same dosage as above (n = 32) Treatment was for 8 weeks The trial ran from October 2014 to December 2014 |
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Outcomes | Pregnancy rates (biochemical) Hormone levels |
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Notes | Conducted in Iran Trial was supported by an institutional grant. Clinical trial number: IRCT201412295623N33 Contact details: Dr Z Asemi; asemi_r@yahoo.com. Email sent 18th October 2016 regarding clinical pregnancy data and block size. No reply |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | "patients with PCOS were randomly divided into 2 groups" "Patient allocation and block size were obtained using random number tables". |
Allocation concealment (selection bias) | Low risk | "At the time of randomization,sequentially numbered, sealed envelopes were opened. Allocation to study group was concealed until the main analyses were completed". |
Blinding (performance bias and detection bias) All outcomes | Low risk | Supplements and placebos were in the same form of package and the participants and researcher were not conscious of the content of the pack until the end of trial |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Reasons and numbers for dropouts from each group were provided. ITT used in the analysis |
Selective reporting (reporting bias) | Low risk | None noted |
Other bias | Low risk | No other bias found |