Ignite Creation Date:
2025-12-25 @ 3:46 AM
Ignite Modification Date:
2026-02-28 @ 3:52 AM
Study NCT ID:
NCT02626702
Status:
TERMINATED
Last Update Posted:
2019-09-16
First Post:
2015-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immune Modulators and IVF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D057832', 'term': 'Watchful Waiting'}], 'ancestors': [{'id': 'D017063', 'term': 'Outcome Assessment, Health Care'}, {'id': 'D010043', 'term': 'Outcome and Process Assessment, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Lab close down', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-31'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-11', 'studyFirstSubmitDate': '2015-12-07', 'studyFirstSubmitQcDate': '2015-12-09', 'lastUpdatePostDateStruct': {'date': '2019-09-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-08-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To explore the relationship between immune mediators and IVF outcome prospectively in women who receive in vitro fertilization treatment.', 'timeFrame': '35 days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['immune modulators', 'IVF outcomes', 'relationship'], 'conditions': ['In Vitro Fertilization']}, 'descriptionModule': {'briefSummary': 'Exploring the immune mediators of early pregnancy prospectively may help to identify new early interventions that will increase the likelihood of success and help women make informed decisions regarding their pregnancies.', 'detailedDescription': 'Sera will be obtained from 500 women undergoing IVF at five time periods: cycle Day 2, post HCG, Day 24, Day 28, and/or Day 35.Aliquots of sera will be tested by commercial ELISA kits for concentrations of immune modulators suggestive to be predictive of IVF outcome, such as cytokines (interleukins, tumor necrosis factor, and interferon), neurotrophins (BDNF), protease inhibitors (HE4) and insulin-like growth factors (IGF-1, IGF-2, IGFBP). The results will be correlated with IVF outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing In Vitro Fertilization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All fresh transfers\n\nExclusion Criteria:\n\n* PGD'}, 'identificationModule': {'nctId': 'NCT02626702', 'briefTitle': 'Immune Modulators and IVF', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'Immune Modulators in Women Undergoing IVF----a Prospective Study', 'orgStudyIdInfo': {'id': '1502015953'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Observational', 'type': 'OTHER', 'description': 'Excess blood from subjects will be analyzed to explore the relationship between Immune Modulators and IVF outcomes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Steven Spandorfer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}