Danazol Treatment in Endometriosis Women Before IVF

• Sponsor: Centre for Endocrinology and Reproductive Medicine, Italy (Other)
• Overall Status: Completed
• CT.gov ID: NCT01779232
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arms: 2
• Duration (Months): 35
• Patients Per Site Per Month: 4.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometriosis; Ovarian Cysts; Infertility	Drug: Danazol; Drug: placebo	Phase 4

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 150 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF
• Study Start Date: Oct 1, 2012
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: control patients treated with placebo for at least 4 months before IVF attempt	Drug: placebo; administered daily like the active comparator
Active Comparator: danazol patients treated with danazol (100mg/day)for at least 4 months before IVF attempt	Drug: Danazol; 100 mg day for 4 monthh in women with diagnosed endometriosis before IVF; Other Names: Danatrol

Outcome Measures

Primary Outcome Measures

1. pregnancy rate [12 months]

   number of ongoing pregnancy for the number of IVF cycles

Secondary Outcome Measures

1. implantation rate [12 months]

   number of embryos implanted for the total number of embryos transferred

Other Outcome Measures

1. number of mature oocyte collected [12 months]

   number of mature oocyte collected for patient undergoing IVF

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CERM	Rome		Italy	00153

Sponsors and Collaborators

• Centre for Endocrinology and Reproductive Medicine, Italy

Investigators

• Study Chair: Marco Sbracia, MD, Centre for Endocrinology and Reproductive Medicine, Italy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fabio Scarpellini, Investigator, Centre for Endocrinology and Reproductive Medicine, Italy
• ClinicalTrials.gov Identifier: NCT01779232
• Other Study ID Numbers: CR-09-2013
• First Posted: Jan 30, 2013
• Last Update Posted: Apr 27, 2016
• Last Verified: Apr 1, 2016

• Keywords provided by Fabio Scarpellini, Investigator, Centre for Endocrinology and Reproductive Medicine, Italy: endometriosis; ivf; ovarian reserve; danazol
• Additional relevant MeSH terms: Ovarian Cysts; Infertility; Endometriosis; Danazol

Study Results

No Results Posted as of Apr 27, 2016