Male Reproduction COVID Sequelae Study (MARCOS).

NCT ID: NCT04665258

Last Updated: 2023-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-14

Study Completion Date

2023-11-28

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility, Male

Keywords

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COVID-19 Vaccine

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Ranjith Ramasamy, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ranjith Ramasamy, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Countries

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United States

Other Identifiers

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20201451

Identifier Type: -

Identifier Source: org_study_id