Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00286351
Status:
COMPLETED
Last Update Posted:
2007-04-23
First Post:
2006-02-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004715', 'term': 'Endometriosis'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D000077384', 'term': 'Anastrozole'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D009570', 'term': 'Nitriles'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-04', 'lastUpdateSubmitDate': '2007-04-20', 'studyFirstSubmitDate': '2006-02-01', 'studyFirstSubmitQcDate': '2006-02-01', 'lastUpdatePostDateStruct': {'date': '2007-04-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-02-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'size of endometriomas after 2½ month of combined downregulation'}]}, 'conditionsModule': {'conditions': ['Endometriosis']}, 'descriptionModule': {'briefSummary': 'Does a combination of Arimidex and Zoladex make endometriomas shrink and how is the following IVF outcome'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Endometrioma(s)with a size of 20-70 mm, persisted for at least 3 cycles\n* Couples with indication and wish for IVF/ICSI\n* Age of women: 20-40 years\n* Regular menstrual cycle within normal range (21-35 days)\n* Body Mass Index (BMI): 18-30 kg/m2\n\nExclusion Criteria:\n\n* History with osteoporosis, liver-, kidney- or heart disease or thromboembolic disease\n* Treatment of endometriosis with GnRH agonist during the last 3 month'}, 'identificationModule': {'nctId': 'NCT00286351', 'briefTitle': 'Use of Arimidex and Zoladex as Pretreatment to IVF in Women With Ovarian Endometriosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'orgStudyIdInfo': {'id': 'endo 220604'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Combined treatment with Arimidex and Zoladex before IVF', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Copenhagen East', 'country': 'Denmark', 'facility': 'The Fertility Clinic, Copenhagen University Hospital, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'overallOfficials': [{'name': 'Kristine Lossl, medical doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Fertility Clinic, Copenhagen University Hospital Rigshospitalet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}}}}