Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2026-03-27 @ 7:30 PM
Study NCT ID:
NCT03953859
Status:
COMPLETED
Last Update Posted:
2022-01-14
First Post:
2019-05-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Embryo DNA Repair Capacity Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-13', 'studyFirstSubmitDate': '2019-05-13', 'studyFirstSubmitQcDate': '2019-05-15', 'lastUpdatePostDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'repair of double strand break in DNA', 'timeFrame': 'up to 12 days', 'description': 'targeted deep sequencing to identify the presence of the double strand break in the DNA and subsequent repair ability of the embryo'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility']}, 'descriptionModule': {'briefSummary': 'The mail aim of the present study is to use molecular methods to analyze the ability of human preimplantation embryos to repair their DNA', 'detailedDescription': 'The main aim of the present study is to investigate the DNA repair pathways of preimplantation embryos, examining the events that take place following induction of a DSB at a unique targeted site. The investigators aim to address questions concerning the functionality of the DNA repair mechanism(s) in developing embryos, before and after genome activation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '42 Years', 'minimumAge': '21 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Healthy volunteer subjects will be recruiting from amongst the gamete donor population and patients undergoing in vitro fertilization (IVF) for treatment of their infertility', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* gamete donors: be at least 21 years of age, in good health and eligible to donate their games through the standard gamete donation programs\n* IVF couples: any couples proceeding with a routine IVF cycle\n\nExclusion Criteria:\n\n* less than 21 years of age\n* inability to provide informed consent'}, 'identificationModule': {'nctId': 'NCT03953859', 'briefTitle': 'Embryo DNA Repair Capacity Project', 'organization': {'class': 'OTHER', 'fullName': 'Reproductive Medicine Associates of New Jersey'}, 'officialTitle': 'Investigation of Cellular DNA Repair Capacity in Human Preimplantation Embryos', 'orgStudyIdInfo': {'id': 'RMA-UK-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Gamete donors', 'description': 'healthy male and female game donors to undergo routine gamete donation process', 'interventionNames': ['Genetic: double strand break']}, {'label': 'Infertile Couple', 'description': 'Couples undergoing routine IVF to treat their infertility'}], 'interventions': [{'name': 'double strand break', 'type': 'GENETIC', 'description': 'an induction of a double strand break will be made in the embryos generated for this research and the repair mechanism observed', 'armGroupLabels': ['Gamete donors']}]}, '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}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Reproductive Medicine Associates of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}