Ignite Creation Date:
2025-12-24 @ 1:49 PM
Ignite Modification Date:
2026-01-02 @ 2:54 AM
Study NCT ID:
NCT01422395
Status:
COMPLETED
Last Update Posted:
2014-06-04
First Post:
2011-08-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005615', 'term': 'Freezing'}], 'ancestors': [{'id': 'D044367', 'term': 'Phase Transition'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D003080', 'term': 'Cold Temperature'}, {'id': 'D013696', 'term': 'Temperature'}, {'id': 'D013816', 'term': 'Thermodynamics'}, {'id': 'D055598', 'term': 'Chemical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-06', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-06-03', 'studyFirstSubmitDate': '2011-08-22', 'studyFirstSubmitQcDate': '2011-08-23', 'lastUpdatePostDateStruct': {'date': '2014-06-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'fertilization rate', 'timeFrame': '18 hours after insemination'}, {'measure': 'Embryo Quality', 'timeFrame': 'day 3 and day 5'}, {'measure': 'Embryo Development', 'timeFrame': 'Day 3 and day 5'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Vitrification', 'Egg Freezing', 'Oocyte Cryopreservation'], 'conditions': ['Fertility']}, 'descriptionModule': {'briefSummary': 'Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '37 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy\n* Day 2-4 FSH \\< 10 IU/ml, LH \\<12 IU/ml, and E2 \\<50 pg/ml\n* Antimullerian Hormone (AMH) \\>1.5\n* Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle\n* BMI \\>18 and \\<32\n\nExclusion Criteria:\n\n* Smokers\n* Polycystic Ovarian Syndrome (PCO)'}, 'identificationModule': {'nctId': 'NCT01422395', 'briefTitle': 'Effect of Oocyte Vitrification on Fertilization Rate, Embryo Quality and Development', 'organization': {'class': 'OTHER', 'fullName': 'Main Line Fertility Center'}, 'officialTitle': 'A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development', 'orgStudyIdInfo': {'id': 'MLFC-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'freezing', 'interventionNames': ['Procedure: Freezing']}, {'type': 'NO_INTERVENTION', 'label': 'No freezing'}], 'interventions': [{'name': 'Freezing', 'type': 'PROCEDURE', 'description': 'Vitrification', 'armGroupLabels': ['freezing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19010', 'city': 'Bryn Mawr', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Main Line Fertility Center', 'geoPoint': {'lat': 40.30396, 'lon': -80.08672}}], 'overallOfficials': [{'name': 'Glassner J Michael, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Main Line Fertility Center'}, {'name': 'Sharon H. Anderson, Ph.D', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Main Line Fertility Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Main Line Fertility Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}