Danazol Treatment in Endometriosis Women Before IVF

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Centre for Endocrinology and Reproductive Medicine, Italy
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: December 2, 2013
Last verified: December 2013
  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:


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


Estimated Enrollment: 150
Study Start Date: October 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: January 2014 (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
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

Contacts
Contact: Marco Sbracia, MD +393479037433 marcandrea@hotmail.com
Contact: Daniela Marconi, MD +39065810461 quelidebercia@hotmail.com

Locations
Italy
CERM Recruiting
Rome, Italy, 00153
Contact: Marco Sbracia, MD    +393479037433    marcandrea@hotmail.com   
Contact: Daniela Marconi, MD    +39065810461    quelidebercia@hotmail.com   
Principal Investigator: Fabio Scarpellini, MD         
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

No publications provided

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: December 2, 2013
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:
Endometriosis
Infertility
Ovarian Cysts
Genital Diseases, Female
Genital Diseases, Male
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Gonadal Disorders
Endocrine System Diseases
Danazol
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014