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

U

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)

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

Trial contacts and locations

1

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Central trial contact

Michael De Brucker, MD PHD; Valerie Uvin, MD

Data sourced from clinicaltrials.gov

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