Zakherah 2011.
| Methods | Parallel randomised controlled trial conducted in Women's Health Centre and Physiology Department, Assiut University, Egypt Timing: January 2007 to December 2009 |
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| Participants | 120 women randomised. Mean age of women in adjusted thermal dose group was 25.7 ± 5.9 years and in the fixed‐dose group was 25.4 ± 5.7 years Inclusion criteria: PCOS (Rotterdam 2003); aged 18 to 38 years, clomiphene‐resistant, anovulatory infertility for 2 years or more, confirmed patent tubes, normal semen analysis from male partner Exclusion criteria: Endocrine abnormalities or pelvic pathology |
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| Interventions | Adjusted thermal dose thermal dose based on ovarian volume (4 to 9 holes delivering a thermal dose of 480 to 1080 J per ovary) (n = 60), versus Fixed 4‐puncture thermal dose 600 J per ovary regardless of size (n = 60) Monopolar diathermy set at 30 W x 5 secs x 4 punctures Follow‐up for 6 months. If no pregnancy after 6 months then evaluated using second‐look laparoscopy for presence of adhesions |
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| Outcomes | Ovulation rate, menstrual cycle regularity, pregnancy. Serum AMH, FSH, AFC and ovarian volume | |
| Notes | Conflict of interest: not stated Clinical trial registration number: not stated |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Quote: "assigned randomly" "computer generated random number table" |
| 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 | 60 women allocated to each group. Adjusted thermal dose group lost 2 women to follow‐up (no reasons provided) analysed 58 women. The fixed‐dose group lost 3 women to follow‐up (no reasons provided), analysed 57 women |
| Selective reporting (reporting bias) | Unclear risk | We could not retrieve the original protocol. Miscarriage rate reported but not prespecified in Methods |
| Other bias | Low risk | Groups balanced at baseline |
AMH: anti‐Müllerian hormone; AFC: antral follicle count; BBT: basal body temperature; BMI: body mass index; CC: clomiphene citrate; FSH: follicle stimulating hormone; hMG: human menopausal (urinary) gonadotrophins; IUI: intra uterine insemination; J: joules; LH: luteinizing hormone; LOD: laparoscopic ovarian drilling; LOE: laparoscopic ovarian electrocautery; OCP: oral contraceptive pill; OHSS: ovarian hyperstimulation syndrome; PCOS: polycystic ovary syndrome; rFSH: recombinant follicle stimulating hormone; THL: transvaginal hydrolaparoscopy; TSH: thyroid stimulating hormone