Danazol Treatment in Endometriosis Women Before IVF

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

ClinicalTrials.gov Identifier:

NCT01779232

First received: January 28, 2013

Last updated: April 25, 2016

Last verified: April 2016

History of Changes

Purpose

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	Intervention	Phase
Endometriosis Ovarian Cysts Infertility	Drug: Danazol Drug: placebo	Phase 4


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF

Resource links provided by NLM:

MedlinePlus related topics: Endometriosis

Drug Information available for: Danazol

U.S. FDA Resources

Further study details as provided by Centre for Endocrinology and Reproductive Medicine, Italy:

Primary Outcome Measures:

pregnancy rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
number of ongoing pregnancy for the number of IVF cycles

Secondary Outcome Measures:

implantation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]
number of embryos implanted for the total number of embryos transferred

Other Outcome Measures:

number of mature oocyte collected [ Time Frame: 12 months ] [ Designated as safety issue: No ]
number of mature oocyte collected for patient undergoing IVF


Enrollment:	150
Study Start Date:	October 2012
Study Completion Date:	September 2015
Primary Completion Date:	August 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Eligibility


Ages Eligible for Study:	18 Years to 40 Years (Adult)
Genders 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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01779232

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


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
Study First Received:	January 28, 2013
Last Updated:	April 25, 2016
Health Authority:	Italy: National Monitoring Centre for Clinical Trials - Ministry of Health

Keywords provided by 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

ClinicalTrials.gov processed this record on September 29, 2016

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