Danazol Treatment in Endometriosis Women Before IVF
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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 |
- pregnancy rate [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]number of ongoing pregnancy for the number of IVF cycles
- implantation rate [ Time Frame: 12 months ] [ Designated as safety issue: No ]number of embryos implanted for the total number of embryos transferred
- 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: | December 2013 |
| Estimated Primary Completion Date: | July 2013 (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 |
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| Contact: Marco Sbracia, MD | +393479037433 | marcandrea@hotmail.com |
| Contact: Daniela Marconi, MD | +39065810461 | quelidebercia@hotmail.com |
| 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 | |
| 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: | January 28, 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 May 19, 2013