Danazol Treatment in Endometriosis Women Before IVF
- Conditions
- Ovarian CystsInfertilityEndometriosis
- Interventions
- Drug: placebo
- Registration Number
- NCT01779232
- Lead Sponsor
- Centre for Endocrinology and Reproductive Medicine, Italy
- Brief 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 150
- Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility
- age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description control placebo patients treated with placebo for at least 4 months before IVF attempt danazol Danazol patients treated with danazol (100mg/day)for at least 4 months before IVF attempt
- Primary Outcome Measures
Name Time Method pregnancy rate 12 months number of ongoing pregnancy for the number of IVF cycles
- Secondary Outcome Measures
Name Time Method implantation rate 12 months number of embryos implanted for the total number of embryos transferred
Trial Locations
- Locations (1)
CERM
🇮🇹Rome, Italy