Corona Virus Infection, COVID-19, Sars-CoV2, Semen
Conditions
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTEjaculated semen sample
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.
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| detection of SARS-CoV-2 in the semen | within 7 days after positive testing for SARS-CoV-2 | detection of SARS-CoV-2 in the semen of men positive for SARS-CoV-2 on nasopharyngeal swab |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| semen viscosity | from first until last semen analysis, upto 15 weeks | viscosity of semen will be assessed macroscopically |
| semen volume | from first until last semen analysis, upto 15 weeks | semen volume |
| semen pH | from first until last semen analysis, upto 15 weeks | semen pH |
| duration of SARS-CoV-2 presence in semen | from first positive semen testing until first negative semen testing, upto 15 weeks | in case of a positive SARS-CoV-2 semen sample, for how long stays the virus present in semen |
| Sperm morphology | from first until last semen analysis, upto 15 weeks | Sperm morphology assesment, according to the WHO guidelines of 2010 |
| Sperm density | from first until last semen analysis, upto 15 weeks | Sperm density assesment, according to the WHO guidelines of 2010 |
| Sperm motility | from first until last semen analysis, upto 15 weeks | Sperm motility assesment, according to the WHO guidelines of 2010 |
Countries
Belgium
Contacts
Primary ContactMichael De Brucker, MD PHD
Backup ContactValerie Uvin, MD
Outcome results
None listed