Danazol Treatment in Endometriosis Women Before IVF

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
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 :	October 2012
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	September 2015

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Name: Danatrol

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. pregnancy rate [ Time Frame: 12 months ]
   number of ongoing pregnancy for the number of IVF cycles

Secondary Outcome Measures :

1. implantation rate [ Time Frame: 12 months ]
   number of embryos implanted for the total number of embryos transferred

Other Outcome Measures:

1. number of mature oocyte collected [ Time Frame: 12 months ]
   number of mature oocyte collected for patient undergoing IVF

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 40 Years (Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Italy
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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Fabio Scarpellini, Investigator, Centre for Endocrinology and Reproductive Medicine, Italy
ClinicalTrials.gov Identifier:	NCT01779232 History of Changes
Other Study ID Numbers:	CR-09-2013
First Posted:	January 30, 2013
Last Update Posted:	April 27, 2016
Last Verified:	April 2016

Keywords provided by Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy:

endometriosis; ivf; ovarian reserve; danazol

Additional relevant MeSH terms:

Ovarian Cysts; Cysts; Ovarian Diseases; Infertility; Endometriosis; Genital Diseases, Male; Genital Diseases, Female; Neoplasms	Adnexal Diseases; Gonadal Disorders; Endocrine System Diseases; Danazol; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs