| Methods |
Prospective, double‐blind parallel‐group randomised trial. Allocation by centralised list supplied to pharmacy. Randomisation to each arm by block design. Attrition 10/100 details in quality table. |
| Participants |
Irish study of women attending an infertility unit. Age range 20‐39 years. Mean age MPA group 31.5±2.8 years, placebo group 31.7±3.0 years. Women had to have a history of infertility ≥2 years, undergoing diagnostic laparoscopy as part of infertility work‐up.
Exclusion: ovarian, uterine, tubal defects other than those due to endometriosis, history of cancer, renal or hepatic impairment and diabetes mellitus. Patients with a history of treatment that might have influenced endometriosis within 4 weeks of baseline laparoscopy. |
| Interventions |
MPA 50 mg daily (n=50)
versus
placebo daily (n=50).
Taken for 12 weeks followed up again at 24 weeks and 36 weeks after beginning treatment. |
| Outcomes |
rAFS, pregnancy, pain, clinical variables, physicians evaluation of well‐being, compliance, adverse events. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomisation using block design. |
| Allocation concealment? |
Low risk |
A ‐ adequate. Centralised list was used for allocation which was supplied to the pharmacy. |
| Blinding?
All outcomes |
Unclear risk |
Double‐blind study. Patients were blinded to allocation but no details as to who else was blinded. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
10/100 failed to complete study. One MPA and two placebo women dropped out before beginning treatment. Other reason for withdrawal were depression (n=1 MPA), failure to return (n=1 MPA), dropped out (n= 2 placebo), pregnant (n=3 placebo). Women assessed at 24 weeks were 49 MPA and 48 placebo. |
| Free of selective reporting? |
High risk |
Not followed up to live birth. |
