NCT01779232

Danazol Treatment in Endometriosis Women Before IVF

Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 150 (actual)
• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy · Network
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether pre-treatment with danazol for at least 4 months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.

Detailed description

Endometriosis is a chronic benign disease defined by the presence of endometrial tissue outside the uterine cavity, affecting women in their reproductive age. This disease is clinically characterized by infertility pelvic pain and the presence of ovarian cysts, endometriomas, and affects the about 10% of women. Women with endometriosis when undergo IVF show lower pregnancy rate than general population, and a reduced ovarian reserve, due to the diseases and often to ovarian surgery. The aim of this study is to evaluate if a pre-treatment with danazol, an anti-estrogenic agent, may improve the otcome of IVF cycles in these women

Conditions

• Endometriosis
• Ovarian Cysts
• Infertility

Interventions

Type	Name	Description
DRUG	Danazol	100 mg day for 4 monthh in women with diagnosed endometriosis before IVF
DRUG	placebo	administered daily like the active comparator

Timeline

• Start date: 2012-10-01
• Primary completion: 2015-08-01
• Completion: 2015-09-01
• First posted: 2013-01-30
• Last updated: 2016-04-27

Locations

1 site across 1 country: Italy