Danazol Treatment in Endometriosis Women Before IVF

Centre for Endocrinology and Reproductive Medicine, Italy

Status and phase: Completed; Phase 4

Conditions: Infertility; Ovarian Cysts; Endometriosis

Treatments: Drug: Danazol; Drug: placebo

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT01779232

CR-09-2013

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility

Exclusion criteria

• age more than 40 years systemic disease antimulleran hormone (AMH)<1 and FSH>20

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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150 participants in 2 patient groups, including a placebo group

control

Placebo Comparator group

Description:

patients treated with placebo for at least 4 months before IVF attempt

Treatment:

Drug: placebo

danazol

Active Comparator group

Description:

patients treated with danazol (100mg/day)for at least 4 months before IVF attempt

Treatment:

Drug: Danazol