Rezk 2016.
| Methods | Parallel randomised controlled trial. Single centre, Department of Obstetrics and Gynaecology, Menoufia University Hospital, Egypt Timing: October 2014 to July 2015 |
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| Participants | 108 women randomised. Mean age of women in unilateral ovarian drilling group was 29.7 ± 1.5 years and in bilateral ovarian drilling group was 29.8 ± 1.4 years Inclusion criteria: Clomiphene‐resistant PCOS (revised Rotterdam criteria); normal semen analysis for partner, normal uterine cavity, bilateral tubal patency Exclusion criteria: FSH > 15 IU/ml, medical disorders such as diabetes and hypertension, contraindications for laparoscopy, endocrine disorders, hyperprolactinaemia, thyroid disorder, Cushing syndrome, acromegaly, pelvic organ disease, abnormal semen analysis from partner |
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| Interventions | Unilateral ovarian drilling of the larger ovary. Number of punctures was calculated as Np = 60 J/cm3/ 30 W x 4 seconds (n = 52), versus Bilateral ovarian drilling: 5 punctures per ovary at 30 W for 4 seconds. Each ovary received 600 J (n = 53) Follow‐up for 6 months |
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| Outcomes | Ovulation rate, clinical pregnancy, ovarian reserve measures. | |
| Notes | Clinical trial registration number: PACTR201405000757313 No conflict of interest |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "randomly assigned into two groups" "computer generated simple random tables" |
| Allocation concealment (selection bias) | Unclear risk | No details provided . |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | No details provided . |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided . |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 108 women randomised.105 women analysed (2 lost in Unilateral group and 1 lost in Bilateral group ‐ reasons were loss to follow‐up) |
| Selective reporting (reporting bias) | Low risk | All prespecified outcomes were reported |
| Other bias | Low risk | Groups balanced at baseline. No other bias identified |