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Danazol for unexplained subfertilityHughes E, Brown J, Tiffin G
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SummaryDanazol for treating subfertilityThe drug danazol (Danocrine) was the most frequently prescribed medication for endometriosis but has also been tested as a treatment for unexplained subfertility. The review of trials found that there is no evidence that low doses of danazol improve live births/ ongoing pregnancy rates. Other negative factors include adverse effects.
This is a Cochrane review abstract and plain language summary, prepared and maintained by The Cochrane Collaboration, currently published in The Cochrane Database of Systematic Reviews 2010 Issue 1, Copyright © 2010 The Cochrane Collaboration. Published by John Wiley and Sons, Ltd.. The full text of the review is available in The Cochrane Library (ISSN 1464-780X).
This version first published online:
April 25. 1995 AbstractBackgroundThe 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. ObjectivesThe objective of this review was to assess the effect of danazol on live birth rate in women with unexplained subfertility. Search strategyWe 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. Selection criteriaRandomised trials of danazol compared with placebo or no treatment in women with unexplained subfertility. Data collection and analysisData were extracted by two reviewers EH and GT. Main resultsTwo 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 to 9.82; p=0.22). There was no significant difference in clinical pregnancies following treatment (OR 0.14, 95% CI 0.01 to 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 to 10.10; p<0.05). Multiple side effects were reported. Authors' conclusionsAvailable 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. |