Ray 2012.
| Study characteristics | ||
| Methods | Comparative randomised phase III open‐labelled trial Duration and location of the trial: quote: "A comparative, prospective, phase III, open labelled trial study was conducted in the Eden Hospital, Medical College Kolkata between January 2008 and December 2009.“ |
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| Participants |
Inclusion criteria: infertile women aged 20‐35 with PCOS diagnosis based on the Rotterdam criteria 2003 Exclusion criteria: women with hyperprolactinaemia, thyroid disorder, male‐factor infertility, known or suspicious tubal‐factor infertility (endometriosis and pelvic inflammatory disease). Also women with a history of liver and kidney failure, cardiovascular diseases, diabetes, or women who consumed metformin or drugs affecting insulin secretion or CC in the previous 2 months Number of centres: 1, Eden Hopsital, Mecial College Kolkata Number of women randomised: 147; group A letrozole: 69, group B CC: 78 Number of women analysed: group A letrozole: 69, group B CC: 78 Number of withdrawals/exclusions/loss to follow‐up and reasons: 0 Age (y): group A letrozole: 28 (19‐35), group B CC: 29 (20‐35) BMI (kg/m²): group A letrozole: 28.8 (23.2‐34.6), group B CC: 28.5 (24.2‐33.6) Duration of infertility (y): group A letrozole: 2.2, group B CC: 2.4 (SD or range not given) Country: India |
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| Interventions |
Group A: letrozole, 2.5 mg/day given orally for 5 days from cycle day 3‐7 Group B: CC, 100 mg/day given orally for 5 days from cycle day 3‐7 |
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| Outcomes |
Primary outcomes: ovulation rate, average follicular diameter on day 16, number of mature follicles produced by cycle, mean estradiol level on the day of hCG administration, mean endometrial thickness, pregnancy rate Secondary outcomes: miscarriage rate, live birth rate |
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| Notes |
Ethical approval: yes, the trial protocol was approved by the ethical committee of Medical College Kolkata Informed consent: yes, participants were counselled and informed consent was obtained before recruitment Source of funding: quote: “Conflict of interest: the authors hereby declare that they have not received any financial support for this study and there is no conflict of interest.” Power calculation: not stated We contacted Dr Ray by email about randomisation, allocation, blinding, multiple pregnancy rate, and OHSS, but he did not respond. |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Unclear how randomisation was done |
| Allocation concealment (selection bias) | Unclear risk | Unclear how allocation was done |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported if anyone was blinded |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported if anyone was blinded |
| Incomplete outcome data (attrition bias) All outcomes | Unclear risk | No participants stated as lost, but 147 participants is an odd number to start with, and so are the groups of 69 and 78 respectively; authors contacted for protocol |
| Selective reporting (reporting bias) | Unclear risk | All expected outcomes were reported, but contacted authors for protocol |
| Other bias | Low risk | None |