Infertility, MaleNCT04665258
Male Reproduction COVID Sequelae Study (MARCOS).
An observational study of Infertility, Male, run by University of Miami.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- Type of treatment
- Vaccines
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 14 Dec 2020to 28 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Young men of reproductive age scheduled for COVID-19 Vaccine
Who may be able to join
- Receiving COVID-19 vaccines
- Male age 18-50 years old
Who cannot join
- 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
About this study
Official title: Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study
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.
- Conditions
- Infertility, Male
- Keywords
- COVID-19 Vaccine
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm concentration
As measured from semen samples.
Measured: up to 6 months
Sperm motility
As measured from semen samples.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start14 Dec 2020
- Primary completion28 Nov 2023
- Study completion28 Nov 2023
Why it stopped: Unable to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ranjith Ramasamy, MD, University of Miami
- Investigators
- Ranjith Ramasamy, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04665258
- Sponsor's protocol ID
- 20201451
- Status last verified
- Nov 2023
- First submitted
- 10 Dec 2020
- Last updated
- 4 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Corona Virus Disease 19 (COVID-19) Vaccine and Impact on Fertility Study
- ClinicalTrials.gov ID
- NCT04665258
- Acronym / sponsor ID
- 20201451
- Conditions
- Infertility, Male
- Keywords
- COVID-19 Vaccine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to recruit participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 14 Dec 2020 (actual)
- Primary completion
- 28 Nov 2023 (actual)
- Study completion
- 28 Nov 2023 (actual)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Young men of reproductive age scheduled for COVID-19 Vaccine
Key inclusion criteria (2 listed)
- Receiving COVID-19 vaccines
- Male age 18-50 years old
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjith Ramasamy, MD principal investigator
University of Miami
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm concentration (time frame: up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2023; AzTrials last refreshed its copy on 31 Oct 2026.