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Danazol Treatment in Endometriosis Women Before IVF

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01779232
First Posted: January 30, 2013
Last Update Posted: April 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
  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
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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • pregnancy rate [ Time Frame: 12 months ]
    number of ongoing pregnancy for the number of IVF cycles


Secondary Outcome Measures:
  • implantation rate [ Time Frame: 12 months ]
    number of embryos implanted for the total number of embryos transferred


Other Outcome Measures:
  • number of mature oocyte collected [ Time Frame: 12 months ]
    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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: January 28, 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:
Infertility
Endometriosis
Ovarian Cysts
Genital Diseases, Male
Genital Diseases, Female
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Danazol
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs