Male Reproduction COVID Sequelae Study (MARCOS).
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ClinicalTrials.gov Identifier: NCT04665258 |
Recruitment Status :
Recruiting
First Posted : December 11, 2020
Last Update Posted : December 16, 2022
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Sponsor:
University of Miami
Information provided by (Responsible Party):
Ranjith Ramasamy, MD, University of Miami
Tracking Information | |||||
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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 |
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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 |
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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.
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status | Recruiting | ||||
Estimated Enrollment |
160 | ||||
Original Estimated Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | ||||
Accepts Healthy Volunteers | Yes | ||||
Contacts |
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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 |
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IPD Sharing Statement |
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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 |
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PRS Account | University of Miami | ||||
Verification Date | December 2022 |