Pilot Study to Detect SARS-CoV-2 Virus in Sperm

Study Overview
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Brief Summary
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This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa. The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.

Detailed Description
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Since the end of 2019, an epidemic of SARS-CoV-2 infections (COVID-19) began in China and is now a global pandemic affecting more than 3 millions of people. Droplets and close contact are the most common routes of transmission of SARS-CoV-2 and aerosol transmission may be another route. Researchers have detected SARS-CoV-2 in samples of respiratory tract, saliva, stool, gastrointestinal tract, urine, tears and conjunctival secretions of COVID-19 patients. Vertical transmission from mother to infant has been suspected, but not confirmed to date. Information about localization of SARS-CoV-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. One of two studies have reported SARS-CoV-2 RNA in semen from six infected patients. However, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa). The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa. This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.

Official Title
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Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.

Conditions
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Covid19

Intervention / Treatment
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* Biological: Sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient aged 18 to 50, male. Patient in acute phase of infection with SARS-CoV-2 and whose RT-PCR shows the viral genome in the nasopharyngeal or salivary sample or in any other sample. Patient who can come to the laboratory for samples Patient having given his free and informed consent and having signed the consent Patient affiliated to a social security scheme or equivalent Exclusion Criteria: Patient having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (WHO standard) Patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (<1.5 mL). Patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples. Patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: SARV-Cov<br>Men will give semen, saliva, urine and blood specimens | Biological: Sample<br>* Men will give semen, saliva, nasopharyngeal, urine and blood specimens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 genomic RNA in patient sperm | Search for presence of SARS-CoV-2 genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SARS-CoV-2 location in patient sperm | Search of location of SARS-Cov-2 in patient sperm after centrifugation | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID19, SARS-CoV Infection, Semen