Hendawy 2011.
| Methods | Randomised controlled clinical trial Duration and location of the trial: not stated |
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| Participants |
Inclusion criteria: quote: "infertile patients (defined as one year of unprotected coitus without conception in patients who have never conceived before) with PCOS, aged younger than 35 years, and attending the infertility out‐ patient clinic at Ain Shams University Hospital and/or a local private outpatient setting. Diagnosis of PCOS was based on the Rotterdam criteria (2003 ESHRE/ ASRM consensus), whereby patients diagnosed with PCOS require the presence of two of three criteria, i.e., oligomenorrhoea and/or anovulation, clinical and/ or biochemical signs of hyperandrogenism, and/or polycystic ovaries on ultrasound. All patients had a history of failed induction of ovulation with appropriately timed intercourse at least 4–6 times." Exclusion criteria: women with infertility due to uterine and tubal pathologies or male factor Number of women randomised: 60 women with primary infertility Number of women analysed: 54 women were analysed, 28 in group 1 (letrozole) and 26 in group 2 (clomiphene citrate) Number of withdrawals/exclusions/loss to follow‐up and reasons: during folliculometry, 2 participants in Group 1 and 4 participants in Group 2 showed no follicular response and were excluded from the study. Number of centres: 2‐centre trial Age (y): group 1 included 30 women aged 21 – 34 (mean ± SD, 27.2 ± 5.18) years, group 2 included 30 women aged 20 – 33 BMI (kg/m²): group 1 included 30 women with a BMI of 24 – 31 (26.2 ± 1.8). Group 2 included 30 women with a BMI of 23 – 32 (29.1 ± 2.3) Duration of infertility (y): mean duration of infertility not reported Country: Egypt |
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| Interventions |
Group A: group 1 included 30 women who were given letrozole (Femara®, Novartis, Basel, Switzerland) orally at a dose of 2.5 mg once daily on days 3 – 7 of the menstrual cycle. Group B: group 2 included 30 women who were given clomiphene citrate (Clomid®, Sano Aventis, France) 50 mg orally twice daily on days 3 – 7 of the menstrual cycle. |
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| Outcomes | Pregnancy rate, multiple pregnancy rate, number of follicles on hCG administration day, endometrial thickness | |
| Notes |
Ethical approval: the study was approved by the medical ethics committee of Ain Shams University Hospital. Informed consent: Informed consent was obtained from all participants Source of funding: not reported Power calculation: none reported |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Participants were randomised using a computer‐generated programme |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | double‐blind randomised, but not reported how blinding was achieved |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | double‐blind randomised, but not reported how blinding was achieved |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 6/60 participants were lost to follow‐up |
| Selective reporting (reporting bias) | Unclear risk | No study protocol was found |
| Other bias | Unclear risk | None |