Clinical trial NCT04391829: Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males
Official title: Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19
Sars-CoV2
Corona Virus Infection
Semen
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2020-05-18
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: detection of SARS-CoV-2 in the semen
timeFrame: within 7 days after positive testing for SARS-CoV-2
Secondary outcomes:
measure: duration of SARS-CoV-2 presence in semen
timeFrame: from first positive semen testing until first negative semen testing, upto 15 weeks
measure: semen viscosity
timeFrame: from first until last semen analysis, upto 15 weeks
measure: semen volume
timeFrame: from first until last semen analysis, upto 15 weeks
measure: semen pH
timeFrame: from first until last semen analysis, upto 15 weeks
measure: Sperm motility
timeFrame: from first until last semen analysis, upto 15 weeks
measure: Sperm morphology
timeFrame: from first until last semen analysis, upto 15 weeks
measure: Sperm density
timeFrame: from first until last semen analysis, upto 15 weeks
Other outcomes:
Locations:
city: Brussels
country: Belgium
facility: UZ Brussel
Study officials:
affiliation: UZ Brussels
name: Michael De Brucker, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.