Male Reproduction COVID Sequelae Study (MARCOS).

• ClinicalTrials.gov Identifier: NCT04665258
• Recruitment Status: Recruiting
• First Posted: December 11, 2020
• Last Update Posted: December 22, 2021
• Sponsor: University of Miami
• Information provided by (Responsible Party): Ranjith Ramasamy, MD, University of Miami

Tracking Information

• First Submitted Date: December 10, 2020
• First Posted Date: December 11, 2020
• Last Update Posted Date: December 22, 2021
• Actual Study Start Date: December 14, 2020
• Estimated Primary Completion Date: June 14, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 10, 2020)

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Male Reproduction COVID Sequelae Study (MARCOS).
• Official Title: Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability Sample
• Study Population: Young men of reproductive age scheduled for COVID-19 Vaccine
• Condition: Infertility, Male
• Intervention: Not Provided

Study Groups/Cohorts

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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 6, 2021): 160
• Original Estimated Enrollment (submitted: December 10, 2020): 60
• Estimated Study Completion Date: June 14, 2023
• Estimated Primary Completion Date: June 14, 2022 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 50 Years (Adult)
• Accepts Healthy Volunteers: Yes

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04665258
• Other Study ID Numbers: 20201451
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Ranjith Ramasamy, MD, University of Miami
• Original Responsible Party: Same as current
• Current Study Sponsor: University of Miami
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Miami
• Verification Date: December 2021