Roy 2009.
Methods | Prospective randomised trial conducted in India Timing: June 2005 to June 2007 |
|
Participants | 44 women with PCOS, normal hysterosalpingography, normal semen parameters in partners; women were also clomiphene‐resistant. Mean age of women in unilateral group was 28.2 ± 12.7 and in the bilateral group was 28.8 ± 2.9 years Exclusion: Other causes of infertility like hypothalamic amenorrhoea, Cushing syndrome, premature ovarian failure, congenital adrenal hyperplasia, androgenic ovarian tumours, endometrial tuberculosis, abnormal TSH and prolactin; had already received other regimens of ovulation induction; tubal obstruction, extensive adhesions of the ovaries or fallopian tubes and endometriosis |
|
Interventions | Unilateral laparoscopic drilling (n = 22), versus Bilateral laparoscopic drilling (n = 22) 5 drills performed per ovary. If there was no ovulation evident within 3 months, the women were started on clomiphene citrate 50 mg daily for 5 days increasing up to a maximum of 150 mg daily for 5 days for a maximum of 6 cycles Follow‐up for 1 year |
|
Outcomes | Clinical and biochemical response, ovulation rate and pregnancy rate | |
Notes | No conflict of interest Clinical trial registration number: not stated |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "..randomly allocated.." Comment: No other details provided |
Allocation concealment (selection bias) | Unclear risk | No details provided |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No evidence of blinding of researchers or participant |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No details provided |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All women randomised appear to have been analysed |
Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. The outcomes listed in the Methods section were reported in the Results |
Other bias | Low risk | No evidence of other risk of bias |