Moussa 2016.
| Study characteristics | ||
| Methods | Randomised controlled clinical trial Duration and location of the trial: quote: "Three hundred and thirty seven infertile women with anovulatory (PCOS) were recruited from the outpatient clinics of both 6th October and Bab Elshaaria University Hospitals from August 2014 and January 2015.“ |
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| Participants |
Inclusion criteria: infertile women with anovulatory (PCOS), age between 20 and 35 years, BMI between 18 kg/m2 and 30 kg/m2, normal uterus and patent tubes by hysterosalpingography, normal semen analysis and normal serum prolactin Exclusion criteria: women with endocrinal disturbance, active liver disease, local disease as hydro‐ or pyosalpinx, and history of previous ovarian surgery Number of women randomised: 150 women Number of women analysed: 150 women were analysed, 50 within each group Number of withdrawals/exclusions/loss to follow‐up and reasons: none Number of centres: 2‐centre trial Age (y): group A: 27.5 ± 4.1, group B: 27.2 ± 3.9, group C: 27.5 ± 4.1 BMI (kg/m²): group A: 26.9 ± 1.7, group B: 26.8 ± 1.7, group C: 26.7 ± 1.5 Duration of infertility (y): group A: 1.9 ± 0.7, group B: 1.9 ± 0.7,and group C: 2.2 ± 0.7 Country: Egypt |
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| Interventions | Each of the 3 groups received 2 tablets for 5 days starting from day 3 to day 7 of the cycle Group A: 100 mg (50 mg/tablet) CC Group B: 5 mg (2.5 mg/tablet) letrozole Group C: 40 mg (20 mg/tablet) tamoxifen |
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| Outcomes |
Primary outcomes: endometrial thickness and endometrial blood flow (PI and RI) Secondary outcomes: development and number of follicles, and the pregnancy rate |
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| Notes |
Ethical approval: the trial was approved by the ethical committee of Al Azhar University. Informed consent: not reported Source of funding: authors declare that they have neither conflict of interest nor received financial support. Power calculation: not reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "The patients were prospectively randomised into three groups each containing fifty patients by computer" |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants randomised were also analysed |
| Selective reporting (reporting bias) | Unclear risk | We found no trial protocol |
| Other bias | Low risk | None |