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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04391829
Other study ID # COVIDSPERM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 31, 2020
Est. completion date August 31, 2021

Study information

Verified date May 2020
Source Universitair Ziekenhuis Brussel
Contact Michael De Brucker, MD PHD
Phone +32494455084
Email michaeldebrucker@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 31, 2021
Est. primary completion date August 31, 2021
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Ejaculated 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.

Locations

Country Name City State
Belgium UZ Brussel Brussels

Sponsors (1)

Lead Sponsor Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Li D, Jin M, Bao P, Zhao W, Zhang S. Clinical Characteristics and Results of Semen Tests Among Men With Coronavirus Disease 2019. JAMA Netw Open. 2020 May 1;3(5):e208292. doi: 10.1001/jamanetworkopen.2020.8292. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary semen viscosity viscosity of semen will be assessed macroscopically from first until last semen analysis, upto 15 weeks
Secondary semen volume semen volume from first until last semen analysis, upto 15 weeks
Secondary semen pH semen pH from first until last semen analysis, upto 15 weeks
Secondary Sperm motility Sperm motility assesment, according to the WHO guidelines of 2010 from first until last semen analysis, upto 15 weeks
Secondary Sperm morphology Sperm morphology assesment, according to the WHO guidelines of 2010 from first until last semen analysis, upto 15 weeks
Secondary Sperm density Sperm density assesment, according to the WHO guidelines of 2010 from first until last semen analysis, upto 15 weeks
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