Seyedoshohadaei 2016.
| Study characteristics | ||
| Methods | Randomised controlled clinical trial Duration and location of the trial: quote: "This double blind clinical trial study was conducted on 100 PCOS infertile women who have not responded to initial treatment, referring to the Infertility Center of Sanandaj Besat Hospital from June 2014 to December 2015.“ |
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| Participants |
Inclusion criteria: PCOS infertile women who have not responded to initial treatment. PCOS was confirmed by Rotterdam criteria (menstrual disturbances: oligomenorrhoea or amenorrhoea, clinical or biochemical hyperandrogenism and sonographic findings of polycystic ovaries). Women with 2 of the 3 PCOS criteria were included in the trial. Exclusion criteria: women with hyperprolactinaemia, thyroid problems and anatomical problem in uterus cavity and fallopian tubes confirmed by hysterosalpangiography, sonohysterography or laparoscopy were excluded from the trial. Number of women randomised: 100 women, 50 to each group Number of women analysed: 100 women, 50 in each group Number of withdrawals/exclusions/loss to follow‐up and reasons: none Number of centres: single centre Age (y): group A (CC + EV) 30.3 ± 3.1; group B (letrozole) 29.6 ± 5.1 BMI (kg/m²): not reported Duration of infertility (y): group A (CC + EV) 3.4 ± 2.8; group B (letrozole) 3.9 ± 2.4 Country: Iran |
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| Interventions |
Group A: 100 mg CC (Iran Hormone Pharmaceutical Company) from day 3‐7 of menstruation and 4 mg estradiol valerate (Aburaihan Pharmacy Company) after the 8th day of menstruation until 14th day Group B: 5 mg letrozole (Iran Hormone Pharmaceutical Company) from day 3‐7 of menstruation with placebo from 8th‐14th day of menstruation |
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| Outcomes | Pregnancy rate, outcome of pregnancy, live birth, miscarriage rate, endometrial thickness | |
| Notes |
Ethical approval: quote: "This study was approved by the Ethics Committee of Kurdistan University of Medical Sciences and has been registered in the Iranian Registry of Clinical Trials with registration number IRCT2015052612789N11." Informed consent: quote: "Written consent was taken before the intervention." Source of funding: quote: "Authors would like to thank Vice Chancellor for Research of Kurdistan University of Medical Sciences to support the study financially. " Power calculation: quote: "The sample size was calculated based on previous studies. Considering the mean of endometrial thickness, 5% type I error and 20% type II error, 45 patients were required in each group. To compensate for possible loss and increase the power of the study, 50 patients were studied in each group." |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Women were block‐randomised and divided in 2 groups |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "To blind the study, transvaginal sonography was performed by a fellow of infertility, the medication was prescribed by a gynaecologist and the patients in group B received placebo." |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "To blind the study, transvaginal sonography was performed by a fellow of infertility, the medication was prescribed by a gynaecologist and the patients in group B received placebo." |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomised were also analysed |
| Selective reporting (reporting bias) | Unclear risk | No trial protocol was found |
| Other bias | Low risk | None |