Danazol for unexplained subfertility.
BACKGROUND
The synthetic androgen Danazol, was developed in the 1970's as a treatment for endometriosis. Its use was soon advocated in women with unexplained subfertility. Two randomised trials were subsequently conducted to assess the effectiveness of danazol in this population.


OBJECTIVE
The objective of this review was to assess the effect of danazol on live birth rate in women with unexplained subfertility.


METHODS
We searched the Cochrane Menstrual Disorders and Sub-fertility Group's specialised register of trials (searched November , 2006) the Cochrane Register of Controlled Trials (The Cochrane Library, Issue 4, 2006), MEDLINE (1966-November 2006), EMBASE (1980 - November 2006) and reference lists of articles.


METHODS
Randomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility.


METHODS
Data were extracted by two reviewers EH and GT.


RESULTS
Two trials involving seventy-one women were included. There was no statistically significant difference in the live birth/ ongoing pregnancy rate between danazol and placebo at the end of treatment (OR 1.16, 95% CI 0.0 to 8.29; P=0.36) or at the end of follow-up (OR 2.41; 95% CI 0.59, 9.82; P=0.22). There was no significant difference in clinical pregnancies following treatment (OR 0.14, 95% CI 0.01, 2.26; P=0.17), however there were significantly more clinical pregnancies during the follow-up period in the danazol group compared with the placebo group (OR 3.15, 95%CI 0.98, 10.10; P<0.05). Multiple side effects were reported.


CONCLUSIONS
Available data demonstrate no evidence of the benefit of danazol for unexplained subfertility. Although there is insufficient evidence to be certain of this, the need for contraception during treatment and the adverse effects and costs of danazol, make its use for this problem unwarranted. The increased pregnancy rate in the long term follow-up data may be attributable to additional therapies and did not influence the live birth/ongoing pregnancy data.
Hughes
E
E
McMaster University, Department of Obstetrics and Gynaecology, 1200 Main St West, Room HSC-4F7, Hamilton, Ontario, CanadaL8N 3Z5. hughese@mcmaster.ca
Brown
J
J
Tiffin
G
G
Vandekerckhove
P
P
D003613:Danazol / Q000627:therapeutic use*; D004965:Estrogen Antagonists / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000188:drug therapy*
D004965:Estrogen Antagonists; D003613:Danazol