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

Universitair Ziekenhuis Brussel

Status: Unknown

Conditions: Sars-CoV2; COVID-19; Corona Virus Infection; Semen

Treatments: Diagnostic Test: Ejaculated semen sample

Study type: Interventional

Funder types: Other

Identifiers

NCT04391829

COVIDSPERM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 estimated patients

Sex: Male

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

SARS-CoV-2 positive men

Experimental group

Description:

Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab.

Treatment:

Diagnostic Test: Ejaculated semen sample