Danazol Treatment in Endometriosis Women Before IVF

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01779232
• Other study ID #: CR-09-2013
• Status: Completed
• Phase: Phase 4
• First received: January 28, 2013
• Last updated: April 25, 2016
• Start date: October 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2016
• Source: Centre for Endocrinology and Reproductive Medicine, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: September 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Endometriosis
• Infertility
• Ovarian Cysts

Intervention

Drug:
• Danazol
100 mg day for 4 monthh in women with diagnosed endometriosis before IVF
• placebo
administered daily like the active comparator

Locations

Country	Name	City	State
Italy	CERM	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Centre for Endocrinology and Reproductive Medicine, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	number of mature oocyte collected	number of mature oocyte collected for patient undergoing IVF	12 months	No
Primary	pregnancy rate	number of ongoing pregnancy for the number of IVF cycles	12 months	Yes
Secondary	implantation rate	number of embryos implanted for the total number of embryos transferred	12 months	No