Danazol Treatment in Endometriosis Women Before IVF

NCT ID: NCT01779232

Last Updated: 2016-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2015-09-30

Brief Summary

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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

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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

Conditions

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Endometriosis Ovarian Cysts Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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control

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

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

administered daily like the active comparator

danazol

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

Group Type ACTIVE_COMPARATOR

Danazol

Intervention Type DRUG

100 mg day for 4 monthh in women with diagnosed endometriosis before IVF

Interventions

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Danazol

100 mg day for 4 monthh in women with diagnosed endometriosis before IVF

Intervention Type DRUG

placebo

administered daily like the active comparator

Intervention Type DRUG

Other Intervention Names

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Danatrol

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre for Endocrinology and Reproductive Medicine, Italy

NETWORK

Sponsor Role lead

Responsible Party

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Fabio Scarpellini

Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marco Sbracia, MD

Role: STUDY_CHAIR

Centre for Endocrinology and Reproductive Medicine, Italy

Locations

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CERM

Rome, , Italy

Site Status

Countries

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Italy

Other Identifiers

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CR-09-2013

Identifier Type: -

Identifier Source: org_study_id

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