Parazzini 1994.
| Methods | Location: University centres in Italy
No. of centres: 6 Recruitment period: January 1990 to July 1991 |
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| Participants | Inclusion criteria: age < 38 yrs, normal medical examination, unexplained infertility for at least 1 year, with/without chronic pelvic pain, endometriosis stage III‐IV, partners with normal sperm analysis and post‐coital tests Exclusion criteria: previous laparoscopic/clinical diagnosis of endometriosis, other diseases that might cause infertility or pelvic pain, previous treatment for endometriosis or infertility No. randomised: 75 No. analysed: 75 (pregnancy rates), 68 (pain scores) | |
| Interventions | Post‐surgical medical therapy Gr A (n=36): nafarelin nasal 400 μg daily x 3/12 Gr B (n=39): placebo | |
| Outcomes | Pain (multidimensional and 10‐point linear scale) score at 12 months Pregnancy rates Adverse drug outcome (amenorrhoea) | |
| Notes | Power calculation: yes (post‐hoc?) Funding: Recordati Milan provided nafarelin | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | "computer generated randomization list" |
| Allocation concealment (selection bias) | Low risk | assigned by telephone call 7 days from surgery |
| Blinding (performance bias and detection bias) All outcomes | Low risk | double blind but authors acknowledge that adverse effects of treatment make maintaining blinding difficult |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | no losses to follow up, all randomised patients included in analyses |
| Selective reporting (reporting bias) | Low risk | pregnancy rate and pelvic pain reported |
| Other bias | Low risk | groups appear comparable at baseline |