Ignite Creation Date:
2025-12-24 @ 12:44 PM
Ignite Modification Date:
2025-12-29 @ 4:09 AM
Study NCT ID:
NCT01219361
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-02-07
First Post:
2010-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Donated Human Embryos Following in Vitro Fertilization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Donated embryos'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-04', 'studyFirstSubmitDate': '2010-10-08', 'studyFirstSubmitQcDate': '2010-10-08', 'lastUpdatePostDateStruct': {'date': '2025-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-10-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freezing methods for embryos', 'timeFrame': 'duration of the study', 'description': 'To test, standardize and implement better methods for the freezing of embryos prior to these techniques being implemented in the clinical setting.'}], 'secondaryOutcomes': [{'measure': 'Development of New Methods', 'timeFrame': 'duration of the study', 'description': 'The development of new methods to optimize the determination of genes and chromosomes in embryos'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Donated embryos'], 'conditions': ['Validation of Laboratory Techniques', 'Validation of Laboratory Methods', 'Assessment of Laboratory Staff Proficiency']}, 'descriptionModule': {'briefSummary': 'Couples who have created excess embryos while undergoing IVF procedures, and who do not wish to transfer those embryos or donate them to another couple may donate the extra embryos to research. The embryos are then used to develop improved laboratory techniques and conditions as well as testing the proficiency of laboratory staff.', 'detailedDescription': 'Undergoing IVF treatment often results in the production of more embryos than can safely be transferred at one time. These extra embryos are often cryopreserved for future use. In the event that a couple decides that they do not want to proceed with using cryopreserved embryos, these embryos can be discarded, donated to another couple, or donated to research.\n\nEmbryos that are donated to research are used to identify a group of parameters that have significant predictive value for assisted reproductive technology outcomes. We hope to develop future laboratory techniques as we gain a better knowledge of gamete development, fertilization and implantation. We will test, standardize and implement better methods for freezing embryos prior to employing these techniques in a clinical setting. We hope to develop new methods to optimize the determination of genes and chromosomes in embryos. We will test the proficiency of laboratory staff on techniques and/or procedures done in the IVF laboratory. This study WILL NOT:create embryos for research, transfer embryos to an individual, develop cell lines or clones.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients will cryopreserved embryos who do not want to discard them or donate them to another couple', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nnone\n\nExclusion Criteria:\n\nnone'}, 'identificationModule': {'nctId': 'NCT01219361', 'briefTitle': 'Evaluation of Donated Human Embryos Following in Vitro Fertilization', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Evaluation of Donated Human Embryos for Study of Normal and Abnormal Differentiation and Development Following in Vitro Fertilization.', 'orgStudyIdInfo': {'id': 'RMA-00-05'}}, 'contactsLocationsModule': {'locations': [{'zip': '07920', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Reproductive Medicine Assoicates of New Jersey', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}], 'overallOfficials': [{'name': 'Thomas Molinaro, MD, MSCE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Reproductive Medicine Associates of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}