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. 2004 Jul 19;2004(3):CD003678. doi: 10.1002/14651858.CD003678.pub2

Parazzini 1994.

Methods Location: University centres in Italy 
 No. of centres: 6
Recruitment period: January 1990 to July 1991
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