| Methods |
Multicentre (n=8). Randomisation was by computer‐generated randomisation list. Insufficient details of allocation concealment. Women and investigators were blinded to regimen. No loss to follow up. |
| Participants |
Italian study of women (n=75) with unexplained or primary infertility. Women were <38, diagnosis of unexplained primary or secondary infertility of >=1 year with or without chronic pain with Stage III or IV disease (rAFS). Women had undergone laparotomy as first surgical treatment for debulking or radical surgery of endometriotic lesions. Normal results on standard medical and gynaecological examinations and hysterosalpingogram, luteal‐phase endometrial biopsy, hormone profile and post coital test.
Exclusion: previous clinical or laparoscopic diagnosis of endometriosis or other disease which might affect fertility or be related with pelvic pain. Partners with dyspermia also resulted in exclusion. Previous therapy for infertility or endometriosis. |
| Interventions |
Nafarelin IN 400 µg per day (N=36)
versus
placebo IN (n=39) administered for 3 months. Women were followed up every 4 months for 1 year. |
| Outcomes |
Gynaecological examination, pregnancy, pelvic pain. |
| Notes |
No details of funding, no details of power calculation. All women randomised were analysed. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
'Computer generated randomization list'. |
| Allocation concealment? |
Unclear risk |
B ‐ unclear, 'assigned by phone'. No details as to who or how this was performed. |
| Blinding?
All outcomes |
Unclear risk |
'Both patients and investigators were blinded' no details as to how this was done. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
No loss to follow up. |
| Free of selective reporting? |
High risk |
Not followed up to live birth. |
