Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-25 @ 7:28 PM
Study NCT ID:
NCT03078569
Status:
UNKNOWN
Last Update Posted:
2017-03-13
First Post:
2017-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], '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': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-08', 'studyFirstSubmitDate': '2017-03-08', 'studyFirstSubmitQcDate': '2017-03-08', 'lastUpdatePostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of retrieved oocytes', 'timeFrame': '2 year', 'description': 'number of oocytes'}], 'secondaryOutcomes': [{'measure': 'number of clinical pregnancies', 'timeFrame': '2.5 years', 'description': 'number of pregnancies with fetal cardiac activity'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Poor responders'], 'conditions': ['Infertility, Female']}, 'descriptionModule': {'briefSummary': 'This study evaluates the efficacy of pre- IVF treatment with transdermal testosterone to enhance ovarian response in poor responders.\n\na randomized controlled trial with two groups, treatment group with transdermal testosterone before IVF treatment and a control group with no treatment.', 'detailedDescription': 'One of the major challenges of Assisted reproduction technology is treating women with low ovarian response,those women achieve very poor pregnancy rate with IVF.\n\nin recent years there is a focus'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '30 Years', 'genderBased': True, 'genderDescription': 'only women under IVF treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* infertility patients undergoing ART regular menses normal function of thyroid, liver and kidney normal BMI (19.3-28.9) without use of any fertility drugs in the previous two months\n\nExclusion Criteria:\n\n* patients with recurrent implantations failure (3 cycles and more) previous ovarian surgery uncontrolled medical illness severe endometriosis (stage 3-4) contraindication for testosterone use'}, 'identificationModule': {'nctId': 'NCT03078569', 'briefTitle': 'Transdermal Testosterone for Poor Responder Patients Undergoing Controlled Ovarian Stimulation Prior to IVF', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Wolfson Medical Center'}, 'officialTitle': 'Transdermal Testosterone for Poor Responders Undergoing IVF', 'orgStudyIdInfo': {'id': 'wolfson testosterone 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'testosterone gel', 'description': 'testosterone gel treatment group', 'interventionNames': ['Drug: Testosterone gel']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'without testosterone treatment'}], 'interventions': [{'name': 'Testosterone gel', 'type': 'DRUG', 'otherNames': ['testomax'], 'description': 'treatment with testosterone gel', 'armGroupLabels': ['testosterone gel']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Holon', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Amir Mr shalev, MD', 'role': 'CONTACT', 'email': 'amirshalev75@yahoo.com', 'phone': '97235028105'}], 'facility': 'Wolfson MC', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}], 'centralContacts': [{'name': 'amir Mr shalev, MD', 'role': 'CONTACT', 'email': 'amirshalev75@yahoo.com', 'phone': '97235028105'}, {'name': 'ariel Mr weissman, Proffesor', 'role': 'CONTACT', 'email': 'ariel.weissman@gmail.com', 'phone': '97235028106'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wolfson Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'amir shalev', 'investigatorAffiliation': 'Wolfson Medical Center'}}}}