Abu Hashim 2010a.
| Methods | Randomised controlled clinical trial Duration and location of the trial: quote: "The study comprised of 260 women with CC‐resistant PCOS among those attending the Outpatient Clinic in Mansoura University Hospitals, and a private practice setting in the period from August 2006 to March 2009.“ |
| Participants |
Inclusion criteria: infertile women with CC resistance and PCOS based on the Rotterdam criteria 2003. Patent fallopian tubes proved by hysterosalpingography and normal semen analysis for their partners according to the modified criteria of WHO. Exclusion criteria: other causes of infertility, age over 40 years, BMI > 35, contraindication to general anaesthetic, previous history of LOD and women who had received metformin, gonadotropin, oral contraceptives or other hormonal drugs during the preceding 6 months. Women who intended to start a diet or a specific programme of physical activity were also excluded. Number of centres: 2, outpatient clinic in Mansoura University hospitals and a private practice setting Number of women randomised: 260, 128 in the letrozole group and 132 in the LOD group Number of women analysed: 128 in the letrozole group and 132 in the LOD group Number of withdrawals/exclusions/loss to follow‐up and reasons: none Age (y): group A letrozole: 27.3 ± 2.6, group B LOD: 26.4 ± 2.4 BMI (kg/m²): group A letrozole: 26.4 ± 3.3, group B LOD: 26.6 ± 3.6 Duration of infertility (y): group A letrozole: 4.3 ± 1.11, group B LOD: 4.5 ± 1.24 Country: Egypt |
| Interventions |
Group A: letrozole, 2.5 mg/day orally given for 5 days starting from day 3 of the cycle Group B: LOD, laparoscopy was performed using 3‐puncture technique. Each ovary was cauterised at 4 points, each for 4 s at 40 W for a depth of 4 mm with a mixed current, using a monopolar electrosurgical needle. |
| Outcomes |
Primary outcome: ovulation rate Secondary outcomes: midcycle endometrial thickness (mm), biochemical pregnancy/cycle, clinical pregnancy/participant, biochemical miscarriage/cycle, clinical miscarriage/participant and live birth rates |
| Notes |
Ethical approval: yes, the trial was approved by Mansoura University Hospital Research Ethics Committee. Informed consent: yes, all participants gave informed consent before inclusion in the trial. Source of funding: not stated Conflicts of interest: quote:“Conflict of interest statement: We declare that we have no conflict of interest” Power calculation: quote: "Sample size was calculated based on the fact that with an expected rate of ovulation of 70% in the LOD group we needed 244 women to show an absolute increase of 15% in ovulation rate in the letrozole group, with a power of 80% at confidence interval of 95% using a two tailed chi‐square test with a 5% significance level (type alfa error)." Trial was moved to awaiting classification as there are concerns about the validity of the trial data. |