Thomas 1987.
Methods | Double‐blind RCT. Method of allocation not stated. Randomisation method not described. Attrition n=3, see quality table for details. | |
Participants | UK study, 40/98 eligible women. All 40 women were subfertile. Age range 21‐36 years. Endometriosis of all stages; primary or secondary infertility of > 12 months; cycle 25‐35 days with biphasic BBT; normal tubal anatomy by HSG and laparoscopy; normal sperm by WHO criteria; normal thyroid function and prolactin. There had to be no impediment to the collection of oocytes by the tubal fimbria. | |
Interventions | Gestrinone 2.5 mg twice weekly for 24 weeks, n=20
versus
placebo, one tablet twice weekly for 24 weeks, n=20. Follow up for one year. |
|
Outcomes | Cumulative pregnancy rates at 6 and 12 months; AFS score at second‐look laparoscopy in 36 women; pregnancy not reported by stage of disease. | |
Notes | Cumulative conception rates were reported on ITT basis. Other causes of infertility were excluded. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Adequate sequence generation? | Unclear risk | Randomly allocated but no details of randomisation procedure. |
Allocation concealment? | Unclear risk | B ‐ unclear. No details of allocation concealment. |
Blinding? All outcomes | Unclear risk | No details provided on who was blinded. |
Incomplete outcome data addressed? All outcomes | Low risk | Three women from placebo group withdrew, no reasons provided. |
Free of selective reporting? | High risk | Not followed up to live birth. |