Abdellah 2011.
| Methods | Randomised controlled trial Duration and location of the trial: quote: "The present study was conducted from July 15, 2007, to February 28, 2010, at the Women's Health Center, Assiut University, Assiut, Egypt, after approval was received from the Ethics Committee of Assiut University.“ |
| Participants |
Inclusion criteria: all participants met the Rotterdam consensus criteria for the diagnosis of PCOS. Other inclusion criteria included primary or secondary infertility because of anovulation for at least 1 year and clomiphene resistance. CC resistance was defined as lack of ovulation after 6 consecutive induction cycles with 50 mg of CC, then with 150 mg of CC each day for 5 days in each cycle. The male partner of each participant was required to have a normal result on semen analysis and each woman was required to have patent tubes on hysterosalpingography or on a diagnostic laparoscopy. Exclusion criteria: exclusion criteria included age below 20 years or above 35 years; hormonal treatment within 3 months prior to the trial; hyperprolactinaemia (morning plasma prolactin concentration 30 ng/mL or more); any other endocrine, hepatic, or renal disorder; presence of an organic pelvic mass; and a history of abdominal surgery that might have caused pelvic factor infertility. Number of women randomised: 147, 74 in the letrozole group and 73 in the LOD group Number of women analysed: 70 in the letrozole group and 70 in the LOD group Number of withdrawals/exclusions/loss to follow‐up and reasons: 7 women were lost to follow‐up. Number of centres: 1, Women’s Health Center, Assiut University, Assiut Age (y): group A letrozole: 23.9 ± 3.2, group B LOD: 23.6 ± 3.2 BMI (kg/m²): group A letrozole: 27.3 ± 2.6, group B LOD: 27.1 ± 2.6 Duration of infertility (y): group A letrozole: 4.2 ± 1.7, group B LOD: 4.2 ± 1.7 Country: Egypt |
| Interventions |
Group A: letrozole, 5 mg/day given orally for 5 days during cycle days 3‐7 for up to 6 cycles Group B: LOD, triple‐puncture laparoscopy, monopolar diathermy, needle electrode set at 40 W pressed against border of ovary for 4 sec to achieve penetration depths of 7 mm to 8 mm, punctured at 4‐6 points |
| Outcomes |
Primary outcomes: ovulation rate Secondary outcomes: endometrial thickness on the day of hCG injection, rates of clinical pregnancy, spontaneous abortion, live birth and multiple pregnancies |
| 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” Authors contacted about information on OHSS Power calculation: quote: "the sample size required to detect a 25% difference between the 2 groups with a power of 80% was estimated to be 68 patients per group." Trial was moved to awaiting classification as there are concerns about the validity of the trial data. |