Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01223105
Status:
TERMINATED
Last Update Posted:
2013-11-19
First Post:
2010-10-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oocyte Cryopreservation by Slow Freezing and Vitrification
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015925', 'term': 'Cryopreservation'}, {'id': 'D058989', 'term': 'Vitrification'}], 'ancestors': [{'id': 'D014021', 'term': 'Tissue Preservation'}, {'id': 'D016591', 'term': 'Histocytological Preparation Techniques'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D011309', 'term': 'Preservation, Biological'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D044367', 'term': 'Phase Transition'}, {'id': 'D055585', 'term': 'Physical Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'Poor recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-15', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-10-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Oocytes survival after thaw', 'timeFrame': '1 month', 'description': 'Whether each oocyte survives the thawing process'}], 'secondaryOutcomes': [{'measure': 'Fertilization', 'timeFrame': '1 month', 'description': 'Whether each oocyte is successfully fertilized'}, {'measure': 'Implantation', 'timeFrame': '1 month', 'description': 'Whether pregnancy occurs.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['slow freeze', 'cryopreservation', 'vitrification', 'oocyte preservation'], 'conditions': ['Women Diagnosed With Cancer', 'Egg Donors', 'Single Women', 'Failed Sperm Procurement in IVF']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate whether the vitrification technique, as compared to the more traditional slow-cooling technique, leads to higher rates of successful thawing, fertilization, implantation and delivery.', 'detailedDescription': 'Cryopreservation (freezing) of human gametes (unfertilized egg) provides a great potential to preserve or extend fertility in the face of disease and social circumstances (cancer diagnosis, delaying childbirth, single women, etc.). There are two methods for storage of oocytes (unfertilized eggs): slow freezing or vitrification (uses higher concentrations of cryoprotectant and faster cooling rates). Slow freezing is the standard method and has been successful for embryos since 1983 and more recently for oocytes. Recent reports indicate that vitrification may be more successful than slow freezing. The aim of this study is to examine the rate at which frozen eggs survive freezing and thawing, the rate at which the frozen/thawed eggs fertilize with sperm and the pregnancy outcomes of oocyte (egg) vitrification cycles to determine whether the outcomes are similar or better than standard oocyte (egg) cryopreservation (freezing) cycles.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 21 and 50 years, at the time of informed consent.\n* Subjects must agree to undergo intracytoplasmic sperm injection (ICSI)\n\nExclusion Criteria:\n\n* Presence of any medical condition that contraindicates ovarian stimulation, in vitro fertilization or pregnancy.'}, 'identificationModule': {'nctId': 'NCT01223105', 'briefTitle': 'Oocyte Cryopreservation by Slow Freezing and Vitrification', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Longitudinal Evaluation of Vitrification of Human Oocytes', 'orgStudyIdInfo': {'id': 'RMA-2009-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Slow Freezing', 'description': 'oocytes will be frozen by slow freeze/ rapid thaw', 'interventionNames': ['Procedure: slow freeze']}, {'type': 'EXPERIMENTAL', 'label': 'Vitrification', 'description': 'oocytes will be frozen using rapid freezing/rapid thaw', 'interventionNames': ['Procedure: Vitrification']}], 'interventions': [{'name': 'slow freeze', 'type': 'PROCEDURE', 'otherNames': ['Cryopreservation', 'Traditional freezing', 'slow freezing'], 'description': 'Eggs will be placed in a cryo-protected solution and frozen slowly in a programable freezer', 'armGroupLabels': ['Slow Freezing']}, {'name': 'Vitrification', 'type': 'PROCEDURE', 'description': 'Eggs will be placed in a high concentration of cryo-protectant and frozen very quickly by plunging in liquid nitrogen', 'armGroupLabels': ['Vitrification']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard T Scott, MD, HCLD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'RMA of NJ'}, {'name': 'Kathleen Ferry, BS', 'role': 'STUDY_CHAIR', 'affiliation': 'RMA of NJ'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}