Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males

Study Overview
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Brief Summary
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The objectives of the study, 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.

Detailed Description
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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.

Official Title
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Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males

Conditions
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COVID-19, Sars-CoV2, Corona Virus Infection, Semen

Intervention / Treatment
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* Diagnostic Test: Ejaculated semen sample


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SARS-CoV-2 positive men<br>Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab. | Diagnostic Test: Ejaculated semen sample<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection of SARS-CoV-2 in the semen | detection of SARS-CoV-2 in the semen of men positive for SARS-CoV-2 on nasopharyngeal swab | within 7 days after positive testing for SARS-CoV-2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of SARS-CoV-2 presence in semen | in case of a positive SARS-CoV-2 semen sample, for how long stays the virus present in semen | from first positive semen testing until first negative semen testing, upto 15 weeks | 
| semen viscosity | viscosity of semen will be assessed macroscopically | from first until last semen analysis, upto 15 weeks | 
| semen volume | semen volume | from first until last semen analysis, upto 15 weeks | 
| semen pH | semen pH | from first until last semen analysis, upto 15 weeks | 
| Sperm motility | Sperm motility assesment, according to the WHO guidelines of 2010 | from first until last semen analysis, upto 15 weeks | 
| Sperm morphology | Sperm morphology assesment, according to the WHO guidelines of 2010 | from first until last semen analysis, upto 15 weeks | 
| Sperm density | Sperm density assesment, according to the WHO guidelines of 2010 | from first until last semen analysis, upto 15 weeks |