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

Not Applicable

• Conditions: Sars-CoV2; Corona Virus Infection; Semen; COVID-19
• Interventions: Diagnostic Test: Ejaculated semen sample

• Registration Number: NCT04391829
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-15
• Study First Posted: 2020-05-18
• Study Start: 2020-08-31
• Last Update Submitted: 2020-10-26
• Last Update Posted: 2020-10-28
• Primary Completion: 2021-08-31
• Study Completion: 2021-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 20

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SARS-CoV-2 positive men	Ejaculated semen sample	Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Sperm morphology	from first until last semen analysis, upto 15 weeks	Sperm morphology 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
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
semen pH	from first until last semen analysis, upto 15 weeks	semen pH
Sperm density	from first until last semen analysis, upto 15 weeks	Sperm density assesment, according to the WHO guidelines of 2010

Trial Locations

Locations (1)

UZ Brussel; 🇧🇪 Brussels, Belgium