- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391829
Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males (COVIDSPERM)
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), a novel coronavirus reported in late December 2019 in Wuhan, China, has spread world-wide with over 1,000,000 coronavirus disease 2019 (COVID-19) cases reported. New developments in molecular virology and immunobiology of SARS-CoV-2, improve our understanding about COVID-19 prevention, management, and possible long-term effects. Although viral transmission occurs predominantly through respiratory droplets, SARS-CoV-2 has been isolated in blood samples and feces from COVID-19 patients, raising questions about viral shedding in other bodily fluids, including semen, as well as alternative modes of transmission.
The objectives are to describe detection of SARS-CoV-2 in the semen of COVID-19 positive patients, the duration of positive semen and to investigate the impact on semen quality, thereby providing insights into the early impact on male reproductive function.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael De Brucker, MD PHD
- Phone Number: +32494455084
- Email: michaeldebrucker@gmail.com
Study Contact Backup
- Name: Valerie Uvin, MD
- Email: valerieuvin@hotmail.com
Study Locations
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-
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Brussels, Belgium, 1090
- Recruiting
- UZ Brussel
-
Contact:
- valerie uvin, md
- Phone Number: 0032 486073292
- Email: valerieuvin@hotmail.com
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Contact:
- michael de brucker, md phd
- Phone Number: 0032 494455084
- Email: michaeldebrucker@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male
- PCR on nasopharyngeal swab positive for SARS-CoV-2
- Age: ≥ 18y - ≤ 50y
- Signed informed consent
- When undergoing ART treatment: ICSI treatment
Exclusion Criteria:
- Negative test of SARS-CoV-2 on nasopharyngeal swab sample
- History of immunosuppression
- Impossibility to deliver a semen sample at UZ Brussel on a weekly base
- When undergoing ART treatment: IVF treatment
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SARS-CoV-2 positive men
Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab.
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SARS-CoV-2 positive men will be asked to give an ejaculated semen sample, within the seven days after positive testing.
Semen samples will be performed every 7 days, until 2 semen PCR tests are negative and will be retested after 3 months.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
detection of SARS-CoV-2 in the semen
Time Frame: within 7 days after positive testing for SARS-CoV-2
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detection of SARS-CoV-2 in the semen of men positive for SARS-CoV-2 on nasopharyngeal swab
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within 7 days after positive testing for SARS-CoV-2
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
duration of SARS-CoV-2 presence in semen
Time Frame: from first positive semen testing until first negative semen testing, upto 15 weeks
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in case of a positive SARS-CoV-2 semen sample, for how long stays the virus present in semen
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from first positive semen testing until first negative semen testing, upto 15 weeks
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semen viscosity
Time Frame: from first until last semen analysis, upto 15 weeks
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viscosity of semen will be assessed macroscopically
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from first until last semen analysis, upto 15 weeks
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semen volume
Time Frame: from first until last semen analysis, upto 15 weeks
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semen volume
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from first until last semen analysis, upto 15 weeks
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semen pH
Time Frame: from first until last semen analysis, upto 15 weeks
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semen pH
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from first until last semen analysis, upto 15 weeks
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Sperm motility
Time Frame: from first until last semen analysis, upto 15 weeks
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Sperm motility assesment, according to the WHO guidelines of 2010
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from first until last semen analysis, upto 15 weeks
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Sperm morphology
Time Frame: from first until last semen analysis, upto 15 weeks
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Sperm morphology assesment, according to the WHO guidelines of 2010
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from first until last semen analysis, upto 15 weeks
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Sperm density
Time Frame: from first until last semen analysis, upto 15 weeks
|
Sperm density assesment, according to the WHO guidelines of 2010
|
from first until last semen analysis, upto 15 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Michael De Brucker, MD PHD, UZ Brussels
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- COVIDSPERM
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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