Ignite Creation Date:
2025-12-25 @ 12:17 AM
Ignite Modification Date:
2026-01-03 @ 1:33 PM
Study NCT ID:
NCT06454058
Status:
TERMINATED
Last Update Posted:
2025-07-20
First Post:
2024-06-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Euploid Embryo Grade and Maternal Age
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 502}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Preliminary findings of inconsistent embryo grading across sites.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2024-06-06', 'studyFirstSubmitQcDate': '2024-06-06', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Embryo Grade', 'timeFrame': '6 months', 'description': 'Embryo grade for PGT-A confirmed euploid embryos'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Advanced Maternal Age', 'Embryo Grade'], 'conditions': ['Fertility']}, 'referencesModule': {'references': [{'pmid': '36878347', 'type': 'BACKGROUND', 'citation': 'Vitagliano A, Paffoni A, Vigano P. Does maternal age affect assisted reproduction technology success rates after euploid embryo transfer? A systematic review and meta-analysis. Fertil Steril. 2023 Aug;120(2):251-265. doi: 10.1016/j.fertnstert.2023.02.036. Epub 2023 Mar 5.'}]}, 'descriptionModule': {'briefSummary': "Background: Advanced maternal age (AMA) is associated with a reduction in live birth rate (LBR) after ART cycles. The main reason for this reduction is the lower number of oocytes aspirated, the number of developing embryos and the low number of euploid embryos available for transfer. The impact of age on success rates after the transfer of an euploid embryo has been a matter of discussion, with a recent meta-analysis showing a reduction in LBR after the transfer of an euploid blastocyst to women of AMA (1). There could be many reasons for this reduced LBR but they can be categorized into two broad categories - the uterus (including the mother's health) and the embryo (including the oocyte and the sperm).\n\nIt is possible that factors associated with reduced embryo quality would manifest in a lower embryo grade.", 'detailedDescription': 'Objective: To study if there is an association between advanced maternal age and lower embryo grading of euploid embryos.\n\nHypothesis: Advanced maternal age is associated with a lower embryonic grade in euploid embryos.\n\nStudy Design: This is a retrospective cross-sectional study of euploid embryos from patients who have completed IVF with PGT-A testing at a fertility clinic in The Prelude Network (US sites only). A comparison of embryo grade between different age groups (\\<35, 40+) will be done after controlling for baseline demographic characteristics.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients who have completed IVF egg retrieval with PGT-A testing at a fertility clinic in The Prelude Network (US clinics, excluding NYU)\n* PGT biopsy was conducted in 2023,\n* PGT biopsy was performed on blastocyst stage embryo,\n* PGT-A result is euploid.\n\nExclusion Criteria:\n\n* PGT-A result is mosaic,\n* Embryos in which PGT-M was done and were found to be carriers of the mutation,\n* Embryos in which PGT-SR was done and were found to be carriers of the structural rearrangement.'}, 'identificationModule': {'nctId': 'NCT06454058', 'briefTitle': 'Association Between Euploid Embryo Grade and Maternal Age', 'organization': {'class': 'INDUSTRY', 'fullName': 'Inception Fertility Research Institute, LLC'}, 'officialTitle': 'Association Between Euploid Embryo Grade and Maternal Age, a Retrospective Cross-sectional Study', 'orgStudyIdInfo': {'id': 'INC-IIS-2024-004'}}, 'contactsLocationsModule': {'locations': [{'zip': '77081', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Inception Fertility Research Institute, LLC', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inception Fertility Research Institute, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}