Danazol Treatment in Endometriosis Women Before IVF

April 25, 2016 updated by: Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

150

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00153
        • CERM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pregnancy rate
Time Frame: 12 months
number of ongoing pregnancy for the number of IVF cycles
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
implantation rate
Time Frame: 12 months
number of embryos implanted for the total number of embryos transferred
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
number of mature oocyte collected
Time Frame: 12 months
number of mature oocyte collected for patient undergoing IVF
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre for Endocrinology and Reproductive Medicine, Italy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

September 1, 2015

Study Registration Dates

First Submitted

January 28, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 30, 2013

Study Record Updates

Last Update Posted (Estimate)

April 27, 2016

Last Update Submitted That Met QC Criteria

April 25, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-09-2013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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