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

COVID-19 Clinical Trial

— COVIDSPERM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04391829
• Other study ID #: COVIDSPERM
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Corona Virus Infection
• Coronavirus Infections
• COVID-19
• Sars-CoV2
• Semen
• Severe Acute Respiratory Syndrome

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