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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04584593
Acronym
COVSPERM
Enrollment
50
Registered
2020-10-14
Start date
2020-10-02
Completion date
2022-02-28
Last updated
2020-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Covid19

Keywords

COVID19, SARS-CoV Infection, Semen

Brief summary

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

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.

Interventions

BIOLOGICALSample

Men will give semen, saliva, nasopharyngeal, urine and blood specimens

Sponsors

University Hospital, Toulouse
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
SARS-CoV-2 genomic RNA in patient sperm3 monthSearch 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

Secondary

MeasureTime frameDescription
SARS-CoV-2 location in patient sperm3 monthSearch of location of SARS-Cov-2 in patient sperm after centrifugation

Countries

France

Contacts

Primary ContactLouis BUJAN, PR
bujan.l@chu-toulouse.fr05 67 77 10 41

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026