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Male Reproduction COVID Sequelae Study (MARCOS).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04665258
Recruitment Status : Recruiting
First Posted : December 11, 2020
Last Update Posted : December 16, 2022
Sponsor:
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

Study Description
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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
Infertility, Male

Study Design
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Study Type : Observational
Estimated 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 : December 14, 2020
Estimated Primary Completion Date : July 14, 2023
Estimated Study Completion Date : July 14, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Sperm concentration [ Time Frame: up to 6 months ]
    As measured from semen samples.

  2. Sperm motility [ Time Frame: up to 6 months ]
    As measured from semen samples.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Young men of reproductive age scheduled for COVID-19 Vaccine
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04665258


Contacts
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Contact: Manuel Molina, MD 3052434873 m.molina.leyba@miami.edu

Locations
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United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: manuel molina, md    305-243-4873    m.molina.leyba@miami.edu   
Principal Investigator: Ranjith Ramasamy, MD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
More Information
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Responsible Party: Ranjith Ramasamy, MD, Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT04665258    
Other Study ID Numbers: 20201451
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: December 16, 2022
Last Verified: December 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ranjith Ramasamy, MD, University of Miami:
COVID-19 Vaccine
Additional relevant MeSH terms:
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Infertility
Infertility, Male