Ignite Creation Date:
2025-12-25 @ 12:19 AM
Ignite Modification Date:
2025-12-25 @ 10:22 PM
Study NCT ID:
NCT04665258
Status:
WITHDRAWN
Last Update Posted:
2023-12-04
First Post:
2020-12-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Male Reproduction COVID Sequelae Study (MARCOS).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Unable to recruit participants', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-28', 'studyFirstSubmitDate': '2020-12-10', 'studyFirstSubmitQcDate': '2020-12-10', 'lastUpdatePostDateStruct': {'date': '2023-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm concentration', 'timeFrame': 'up to 6 months', 'description': 'As measured from semen samples.'}, {'measure': 'Sperm motility', 'timeFrame': 'up to 6 months', 'description': 'As measured from semen samples.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['COVID-19 Vaccine'], 'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the effects of COVID-19 Vaccination on semen parameters and to determine how long these possible changes may last following vaccination.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Young men of reproductive age scheduled for COVID-19 Vaccine', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Receiving COVID-19 vaccines\n2. Male age 18-50 years old\n\nExclusion Criteria:\n\n1. Adults unable to consent\n2. Women\n3. Prisoners\n4. Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year\n5. Men with a history of Azoospermia\n6. Men with a genetic or other medical condition known to be associated with decreased semen parameters (i.e. Klinefelter's syndrome, Y-Chromosome Microdeletion (YCMD), post-chemotherapy treatment, etc.)\n7. Positive COVID-19 test within the last 3 weeks"}, 'identificationModule': {'nctId': 'NCT04665258', 'briefTitle': 'Male Reproduction COVID Sequelae Study (MARCOS).', 'organization': {'class': 'OTHER', 'fullName': 'University of Miami'}, 'officialTitle': 'Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study', 'orgStudyIdInfo': {'id': '20201451'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COVID-19 vaccine group', 'description': 'Participants scheduled to receive the COVID-19 vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination.'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ranjith Ramasamy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Miami'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Miami', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Ranjith Ramasamy, MD', 'investigatorAffiliation': 'University of Miami'}}}}