Clincosm LogoSign in Get a demo

Male Reproduction COVID Sequelae Study (MARCOS).

Sponsor
University of Miami (Other)
Overall Status
Recruiting
CT.gov ID
NCT04665258
Collaborator
(none)
160
Enrollment
1
Location
24
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    160 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study
    Actual Study Start Date :
    Dec 14, 2020
    Anticipated Primary Completion Date :
    Dec 14, 2022
    Anticipated Study Completion Date :
    Dec 14, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    COVID-19 vaccine group

    Participants scheduled to receive the COVID-19 vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination.

    Outcome Measures

    Primary Outcome Measures

    1. Sperm concentration [up to 6 months]

      As measured from semen samples.

    2. Sperm motility [up to 6 months]

      As measured from semen samples.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    1. Receiving COVID-19 vaccines

    2. Male age 18-50 years old

    Exclusion Criteria:

    1. Adults unable to consent

    2. Women

    3. Prisoners

    4. Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year

    5. Men with a history of Azoospermia

    6. 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.)

    7. Positive COVID-19 test within the last 3 weeks

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136

    Sponsors and Collaborators

    • University of Miami

    Investigators

    • Principal Investigator: Ranjith Ramasamy, MD, University of Miami

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ranjith Ramasamy, MD, Associate Professor, University of Miami
    ClinicalTrials.gov Identifier:
    NCT04665258
    Other Study ID Numbers:
    • 20201451
    First Posted:
    Dec 11, 2020
    Last Update Posted:
    Jun 1, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Ranjith Ramasamy, MD, Associate Professor, University of Miami
    COVID-19 Vaccine
    Additional relevant MeSH terms:
    Infertility
    Infertility, Male

    Study Results

    No Results Posted as of Jun 1, 2022