Methods | Randomised controlled trial | |
Participants | Infertile women with PCOS (n = 44). Natural or timed intercourse Mean age: Treatment group: 26.5 yr (20 ‐ 43); Control group: 29 yrs (23 ‐ 26) Inclusion criteria: primary or secondary infertility due to PCOS according to Rotterdam criteria including oligomenorrhoea, amenorrhoea, clinical or laboratory evidence of increase androgen level or polycystic ovaries in sonography Exclusion criteria: any definite gland disorders such as kaohsiung hypothyroid, hypothyroidism, diabetics and increase in blood prolactin levels |
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Interventions | 1. Clomiphene 50 mg: 1 tablet a day + 400 units of Vitamin D + 1000 mg calcium: 1 tablet a day (n = 22) 2. Clomiphene 50 mg + placebo: 1 tablet a day (n = 22) Duration: 3 menstruation cycles (3 months) |
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Outcomes | Follicle size Pregnancy (unknown whether this is clinical or biochemical ‐ sonography had been done for all participants up to 3 months but this could be to assess follicle size) |
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Notes | Conducted in Iran Trial was run between 2010 and 2011. Funding source not reported Email was sent to author on the 30th November 2015 regarding data and risk of bias robab20@yahoo.com ‐ no reply. Dr Vahid Seyfoddin helped translate key points from the paper. New email found nezhat79@gmail.com, email sent 27th September 2016 regarding block size, allocation concealment and clinical pregnancy data |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Patients were divided into two groups (22 Intervention and 22 controls) using block randomization method". Unknown process of selection of blocks |
Allocation concealment (selection bias) | Unclear risk | Unknown block number |
Blinding (performance bias and detection bias) All outcomes | Low risk | "Specialists did the randomisation only and the residents managed the study, the radiologists was blinded while using the same instrument and only one practitioner" (placebo control) |
Incomplete outcome data (attrition bias) All outcomes | Low risk | "All participants completed the study" |
Selective reporting (reporting bias) | Unclear risk | Unknown whether the reported pregnancies were biochemical or clinical. Protocol available |
Other bias | Low risk | No other bias found |