Gürgan 1992.
| Methods | Randomised trial conducted in Turkey at the University of Hecettepi, Ankara, Turkey. Time of randomisation: after initial laparoscopic ovarian drilling. Timing: not stated | |
| Participants | 40 women randomised, clomiphene‐resistant PCOS patients (see definitions). Mean age (range) of the participants was 25.2 years (21 to 31) and mean duration of infertility was 4.4 years. 33 participants had primary and 7 had secondary infertility. Infertility work‐up consisted of semen analysis (normal in 36 participants and mildly oligo/asthenospermia in 4) and normal HSG. All women were anovulatory There were no clear inclusion or exclusion criteria specified |
|
| Interventions | 2nd look laparoscopic adhesiolysis following ovarian laser drilling, versus Ovarian laser drilling only Ovarian laser drilling consisted of creating 20 to 25 holes/ovary using beam power of 50 W with the Nd:YAG laser followed by pelvic irrigation with Ringer lactate. Laparoscopic adhesiolysis with sharp or blunt dissection was done 3 to 4 weeks later | |
| Outcomes | Pregnancy rate (by participant), ovulation rate (by participant), miscarriage rate (by pregnancy), multiple pregnancy rate (by pregnancy) Follow‐up for 6 months |
|
| Notes | Conflict of interest: not stated Definitions: PCO: clinical (oligomenorrhoea, hirsutism, obesity) + LH/FSH ratio > 2 + elevated testosterone and/or androstenedione (not specified) Clomiphene resistant: failure to ovulate on 200 mg/day for 5 days (duration not stated) Pregnancy: ultrasound (not specified) Ovulation: biphasic BBT + luteal serum progesterone > 3 ng/ml |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "table of random numbers" |
| Allocation concealment (selection bias) | Unclear risk | No details in paper |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | No details in paper but blinding unlikely to have occurred |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 40 women randomised, 1 refused second‐look laparoscopy |
| Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. A priori outcomes in Methods section of paper were reported in Results section |
| Other bias | Low risk | No evidence of other risk of bias |