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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

Tracking Information
First Submitted Date December 10, 2020
First Posted Date December 11, 2020
Last Update Posted Date December 16, 2022
Actual Study Start Date December 14, 2020
Estimated Primary Completion Date July 14, 2023   (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
Change History
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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 6, 2021)		 160
Original Estimated Enrollment
 (submitted: December 10, 2020)		 60
Estimated Study Completion Date July 14, 2023
Estimated Primary Completion Date July 14, 2023   (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
Removed Location Countries  
 
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 2022