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Trial record 2 of 7 for:    danazol | Endometriosis

Danazol Treatment in Endometriosis Women Before IVF

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ClinicalTrials.gov Identifier: NCT01779232
Recruitment Status : Completed
First Posted : January 30, 2013
Last Update Posted : April 27, 2016
Sponsor:
Information provided by (Responsible Party):
Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy

Tracking Information
First Submitted Date  ICMJE January 28, 2013
First Posted Date  ICMJE January 30, 2013
Last Update Posted Date April 27, 2016
Study Start Date  ICMJE October 2012
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
pregnancy rate [ Time Frame: 12 months ]
number of ongoing pregnancy for the number of IVF cycles
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 28, 2013)
implantation rate [ Time Frame: 12 months ]
number of embryos implanted for the total number of embryos transferred
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 28, 2013)
number of mature oocyte collected [ Time Frame: 12 months ]
number of mature oocyte collected for patient undergoing IVF
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Danazol Treatment in Endometriosis Women Before IVF
Official Title  ICMJE Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Endometriosis
  • Ovarian Cysts
  • Infertility
Intervention  ICMJE
  • Drug: Danazol
    100 mg day for 4 monthh in women with diagnosed endometriosis before IVF
    Other Name: Danatrol
  • Drug: placebo
    administered daily like the active comparator
Study Arms  ICMJE
  • Placebo Comparator: control
    patients treated with placebo for at least 4 months before IVF attempt
    Intervention: Drug: placebo
  • Active Comparator: danazol
    patients treated with danazol (100mg/day)for at least 4 months before IVF attempt
    Intervention: Drug: Danazol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 28, 2013)
150
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01779232
Other Study ID Numbers  ICMJE CR-09-2013
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Fabio Scarpellini, Centre for Endocrinology and Reproductive Medicine, Italy
Study Sponsor  ICMJE Centre for Endocrinology and Reproductive Medicine, Italy
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Marco Sbracia, MD Centre for Endocrinology and Reproductive Medicine, Italy
PRS Account Centre for Endocrinology and Reproductive Medicine, Italy
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP