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
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Endometriosis Ovarian Cysts Infertility | Drug: Danazol Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 150 participants |
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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | August 2015 |
Actual Study Completion Date : | September 2015 |

Arm | Intervention/treatment |
---|---|
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
|
- pregnancy rate [ Time Frame: 12 months ]number of ongoing pregnancy for the number of IVF cycles
- implantation rate [ Time Frame: 12 months ]number of embryos implanted for the total number of embryos transferred
- number of mature oocyte collected [ Time Frame: 12 months ]number of mature oocyte collected for patient undergoing IVF

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

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
Italy | |
CERM | |
Rome, Italy, 00153 |
Study Chair: | Marco Sbracia, MD | Centre for Endocrinology and Reproductive Medicine, Italy |
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 Posted: | January 30, 2013 Key Record Dates |
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:
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 |