Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-30 @ 4:33 PM
Study NCT ID:
NCT05894356
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2024-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-16', 'studyFirstSubmitDate': '2023-05-30', 'studyFirstSubmitQcDate': '2023-06-07', 'lastUpdatePostDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigate the impact of advanced paternal age on sperm DNA fragmentation', 'timeFrame': 'Up to 3 weeks', 'description': 'Comparing mean sperm DNA fragmentation throughout the chart review of different age groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects.\n\nRecent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male patients presenting for infertility evaluation from all ages, ethnicities, and medical histories.', 'genderDescription': 'Sperm sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male of at least 18 years of age'}, 'identificationModule': {'nctId': 'NCT05894356', 'acronym': 'Paternal Clock', 'briefTitle': 'The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Clinique Ovo'}, 'officialTitle': 'The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation', 'orgStudyIdInfo': {'id': '3287'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Men undergoing sperm DNA fragmentation test', 'description': 'Men presenting at the clinic for infertility evaluation', 'interventionNames': ['Other: Study chart review']}], 'interventions': [{'name': 'Study chart review', 'type': 'OTHER', 'description': 'Evaluation of 4250 sperm DNA fragmentation samples with the goal of defining a cut-off age beyond which SDF levels increase significantly', 'armGroupLabels': ['Men undergoing sperm DNA fragmentation test']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4P 2S4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Clinique Ovo', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Jacques Kadoch, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clinique Ovo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinique Ovo', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}