| Methods |
Allocation by "randomly selected card".
No details of concealment. No blinding.
Nine danazol and 13 no treatment patients were lost to follow up although no details of reasons. |
| Participants |
USA study. Participants were subfertile couples. Mean age of danazol group 30.33±2.93 years; no treatment group 31.07±3.33 years.
Inclusion: infertility > 12 months; ovulation confirmed by BBT and endometrial biopsy; tubal patency by HSG and/or laparoscopy; normal sperm quality; endometriosis at laparoscopy with no implants > 5mm, only avascular tubal adhesions and at least one ovary free of adhesions; Kistner stage I.
No details of exclusions. |
| Interventions |
Danazol, 800 mg daily for 2 months followed by 600 mg daily for 2 months followed by 400 mg daily for 2 months (n=37)
versus
no treatment, (n=36).
Women were followed up for 12 months immediately after laparoscopy in no treatment group or after completion of danazol. |
| Outcomes |
Clinical pregnancy by serum or urine BhCG. |
| Notes |
Other diagnoses included if "correctable", this presumably includes oligo‐ovulation; follow up for 12 months post‐treatment; life table analysis reported; ITT analysis done. No details of power calculation. No details of funding. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Low risk |
Randomisation by a randomly selected card. |
| Allocation concealment? |
Unclear risk |
Unclear, no details provided. |
| Blinding?
All outcomes |
High risk |
Intervention versus no treatment, therefore no blinding. |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Total loss to follow up was 21/73: n= 9 from danazol group and n=13 from no treatment group. No details given for reason for loss to follow up. |
| Free of selective reporting? |
High risk |
Not followed up to live birth. |
