Begum 2009.
| Methods | Randomised non‐blinded controlled trial Duration and location of the trial: quote: "The study was conducted in a private infertility care setting as a randomized controlled trial between August 2004 and December 2005.“ |
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| Participants |
Inclusion criteria: infertile women with PCOS diagnosed by the Rotterdam criteria 2003 who failed to ovulate by taking 100 mg of CC/day for 5 days in 2 consecutive cycles Exclusion criteria: women with hyperprolactinaemia, thyroid disorder, male‐factor infertility, known or suspicious tubal factor infertility (endometriosis and pelvic inflammatory disease), and unexplained infertility were excluded from the study. Number of centres: 1, private infertility care setting Number of women randomised: 32 in each group Number of women analysed: 32 in each group Number of withdrawals/exclusions/loss to follow‐up and reasons: 0 Age (y): group A letrozole: 25.5 ± 4.0, group B clomiphene citrate: 26.1 ± 3.6 BMI (kg/m²): group A letrozole: 22.7 ± 2.8, group B clomiphene citrate: 23.6 ± 3.2 Duration of infertility (y): group A letrozole: 2.7 ± 1.1, group B clomiphene citrate: 2.6 ± 1.1 Country: India |
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| Interventions |
Group A: letrozole, 7.5 mg/day orally given for 5 days from cycle days 3 ‐ 7 Group B: clomiphene citrate, 150 mg/day orally given for 5 days from cycle days 3 ‐ 7 |
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| Outcomes |
Primary Outcomes: ovulation and pregnancy rate Secondary Outcomes: follicular development by day 16 (mm), serum E2 on day of hCG (pg/mL), endometrial development by day 16 (mm), serum progesterone on day 21 (ng/mL), multiple pregnancies, OHSS cases. Live birth rate was provided by email contact. |
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| Notes |
Ethical approval: yes, the study protocol was approved by the institutional review board (IRB) of Dhaka medical college. Informed consent: yes, participants were counselled and informed consent was obtained before recruitment. Source of funding: the study was self‐funded. Power calculation: a study population of 57 women was calculated, considering an average of 60% of PCOS women are associated with insulin resistance, allowing an alfa value of 0.05. Authors were contacted by email, and additional information was provided. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was done by lottery method. They put the name of letrozole and CC in a sealed opaque envelope. By calculating sample size they made 64 pieces of paper, 32 for letrozole and 32 for CC. |
| Allocation concealment (selection bias) | Unclear risk | Quote: "All unleveled envelop were put together and the patients drew one piece of envelop from them. Then we opened the envelop to see the name of the drug." (by email contact with Prof. Rashida) |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "There was no blinding" (by email contact with Prof. Rashida) |
| Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "There was no blinding" (email with Prof. Rashida) |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No dropouts |
| Selective reporting (reporting bias) | Low risk | All outcomes reported |
| Other bias | Low risk | None |