Ignite Creation Date:
2025-12-24 @ 9:30 PM
Ignite Modification Date:
2026-01-01 @ 9:10 AM
Study NCT ID:
NCT01779232
Status:
COMPLETED
Last Update Posted:
2016-04-27
First Post:
2013-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Danazol Treatment in Endometriosis Women Before IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}, {'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'C565840', 'term': 'Long Qt Syndrome 3'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003613', 'term': 'Danazol'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-04', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-04-25', 'studyFirstSubmitDate': '2013-01-28', 'studyFirstSubmitQcDate': '2013-01-28', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'number of mature oocyte collected', 'timeFrame': '12 months', 'description': 'number of mature oocyte collected for patient undergoing IVF'}], 'primaryOutcomes': [{'measure': 'pregnancy rate', 'timeFrame': '12 months', 'description': 'number of ongoing pregnancy for the number of IVF cycles'}], 'secondaryOutcomes': [{'measure': 'implantation rate', 'timeFrame': '12 months', 'description': 'number of embryos implanted for the total number of embryos transferred'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['endometriosis', 'ivf', 'ovarian reserve', 'danazol'], 'conditions': ['Endometriosis', 'Ovarian Cysts', 'Infertility']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Clinical diagnosis of endometriosis previous laparoscopic surgery for ovarian endometriotic cysts infertility\n\nExclusion Criteria:\n\n\\- age more than 40 years systemic disease antimulleran hormone (AMH)\\<1 and FSH\\>20'}, 'identificationModule': {'nctId': 'NCT01779232', 'briefTitle': 'Danazol Treatment in Endometriosis Women Before IVF', 'organization': {'class': 'NETWORK', 'fullName': 'Centre for Endocrinology and Reproductive Medicine, Italy'}, 'officialTitle': 'Treatment With Danazol Before Controlled Ovarian Hyperstimulation in Women With Endometriosis Undergoing IVF', 'orgStudyIdInfo': {'id': 'CR-09-2013'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'control', 'description': 'patients treated with placebo for at least 4 months before IVF attempt', 'interventionNames': ['Drug: placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'danazol', 'description': 'patients treated with danazol (100mg/day)for at least 4 months before IVF attempt', 'interventionNames': ['Drug: Danazol']}], 'interventions': [{'name': 'Danazol', 'type': 'DRUG', 'otherNames': ['Danatrol'], 'description': '100 mg day for 4 monthh in women with diagnosed endometriosis before IVF', 'armGroupLabels': ['danazol']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'administered daily like the active comparator', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00153', 'city': 'Rome', 'country': 'Italy', 'facility': 'CERM', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Marco Sbracia, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Centre for Endocrinology and Reproductive Medicine, Italy'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Endocrinology and Reproductive Medicine, Italy', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Investigator', 'investigatorFullName': 'Fabio Scarpellini', 'investigatorAffiliation': 'Centre for Endocrinology and Reproductive Medicine, Italy'}}}}