Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-01-09 @ 6:41 PM
Study NCT ID:
NCT03382002
Status:
UNKNOWN
Last Update Posted:
2019-02-01
First Post:
2017-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex and Outcome in IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 322}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-11-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2020-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2017-11-29', 'studyFirstSubmitQcDate': '2017-12-21', 'lastUpdatePostDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Association of parameters of oxidative state with cycle outcome (pregnancy: yes/no)', 'timeFrame': 'two years', 'description': 'The oxidative status in the incubation medium of the cumulus-oocyte complex will be assessed looking for an association between oxidative parameters and cycle outcome (pregnancy: yes/no))'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Oxidative Stress']}, 'descriptionModule': {'briefSummary': 'Medium of cumulus-oocyte complex will be assessed for oxidative status.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing in vitro fertilization', 'genderDescription': 'female only', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n•Patients undergoing in vitro fertilization treatment\n\nExclusion Criteria:\n\n•Patients undergoing intracytoplasmic sperm injection'}, 'identificationModule': {'nctId': 'NCT03382002', 'briefTitle': 'Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex and Outcome in IVF', 'organization': {'class': 'OTHER', 'fullName': 'Carmel Medical Center'}, 'officialTitle': 'Evaluation of Association Between Oxidative Parameters in Fertilization Medium of Cumulus Oocyte Complex (COC( as Measured by the TCL Assay and Clinical and Laboratory Outcome Parameters in IVF', 'orgStudyIdInfo': {'id': 'CarmelMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TCL', 'type': 'DIAGNOSTIC_TEST', 'description': 'evaluation of oxidative status'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Zofnat Wiener, MD', 'role': 'CONTACT', 'email': 'wiener_zofnat@clalit.org.il', 'phone': '97248250335'}], 'facility': 'Carmel medical Center', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}], 'centralContacts': [{'name': 'Zofnat Wiener, MD', 'role': 'CONTACT', 'email': 'wiener_zofnat@clalit.org.il', 'phone': '97248250335'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmel Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Zofnat Wiener', 'investigatorAffiliation': 'Carmel Medical Center'}}}}