NCT04665258

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Dec 2020

Typical duration for all trials

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 11, 2020

Completed
3 days until next milestone

Study Start

First participant enrolled

December 14, 2020

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2023

Completed
Last Updated

December 4, 2023

Status Verified

November 1, 2023

Enrollment Period

3 years

First QC Date

December 10, 2020

Last Update Submit

November 28, 2023

Conditions

Infertility, Male

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

  • Sperm concentration

    As measured from semen samples.

    up to 6 months

  • Sperm motility

    As measured from semen samples.

    up to 6 months

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Young men of reproductive age scheduled for COVID-19 Vaccine

You may qualify if:

  • Receiving COVID-19 vaccines
  • Male age 18-50 years old

You may not qualify if:

  • Adults unable to consent
  • Women
  • Prisoners
  • Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
  • Men with a history of Azoospermia
  • 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.)
  • Positive COVID-19 test within the last 3 weeks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Ranjith Ramasamy, MD

    University of Miami

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

December 10, 2020

First Posted

December 11, 2020

Study Start

December 14, 2020

Primary Completion

November 28, 2023

Study Completion

November 28, 2023

Last Updated

December 4, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share