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COVID-19 Vaccine and Impact on Fertility Study

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. Read our disclaimer for details. Identifier: NCT04665258
Recruitment Status : Completed
First Posted : December 11, 2020
Last Update Posted : July 12, 2021
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami

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

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Study Type : Observational
Actual Enrollment : 60 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
Actual Primary Completion Date : June 14, 2021
Actual Study Completion Date : June 14, 2021

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.

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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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

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

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 identifier (NCT number): NCT04665258

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United States, Florida
University of Miami
Miami, Florida, United States, 33136
Sponsors and Collaborators
University of Miami
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Principal Investigator: Ranjith Ramasamy, MD University of Miami
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Responsible Party: Ranjith Ramasamy, MD, Associate Professor, University of Miami Identifier: NCT04665258    
Other Study ID Numbers: 20201451
First Posted: December 11, 2020    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
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, Male
Respiratory Tract Infections
Pneumonia, Viral
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases