CClinicalTrials.gg
Status unknownNCT04391829COVIDSPERMUpdated Oct 28, 2020

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

An interventional study of Ejaculated semen sample in COVID-19, Sars-CoV2 and Corona Virus Infection, sponsored by Universitair Ziekenhuis Brussel. Status unknown at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2020-10-28.

Sponsored by Universitair Ziekenhuis Brussel · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 50 Years
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • COVID-19
  • Sars-CoV2
  • Corona Virus Infection
  • Semen
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In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 20 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

Universitair Ziekenhuis Brussel is the lead sponsor of 362 studies on the registry; 103 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (estimated)

Study arms

  • Experimental
    SARS-CoV-2 positive men

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

    Diagnostic Test: Ejaculated semen sample

Interventions

  • Diagnostic testEjaculated 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.

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: within 7 days after positive testing for SARS-CoV-2

Secondary outcomes

  1. 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

    Time frame: from first positive semen testing until first negative semen testing, upto 15 weeks

  2. semen viscosity

    viscosity of semen will be assessed macroscopically

    Time frame: from first until last semen analysis, upto 15 weeks

  3. semen volume

    semen volume

    Time frame: from first until last semen analysis, upto 15 weeks

  4. semen pH

    semen pH

    Time frame: from first until last semen analysis, upto 15 weeks

  5. Sperm motility

    Sperm motility assesment, according to the WHO guidelines of 2010

    Time frame: from first until last semen analysis, upto 15 weeks

  6. Sperm morphology

    Sperm morphology assesment, according to the WHO guidelines of 2010

    Time frame: from first until last semen analysis, upto 15 weeks

  7. Sperm density

    Sperm density assesment, according to the WHO guidelines of 2010

    Time frame: from first until last semen analysis, upto 15 weeks

07

Study locations

1 of 1 sites recruiting
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References and documents

Publications

  • 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. Erratum In: JAMA Netw Open. 2020 Jun 1;3(6):e2010845. doi: 10.1001/jamanetworkopen.2020.10845. PubMed 32379329 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04391829
Lead sponsor
Universitair Ziekenhuis Brussel
Responsible party
Sponsor
First posted
May 18, 2020
Start date
Aug 31, 2020
Primary completion
Aug 31, 2021 (estimated)
Completion
Aug 31, 2021 (estimated)
Last update
Oct 28, 2020

Study contacts

Michael De Brucker, MD PHD
Contact
michaeldebrucker@gmail.com
+32494455084
Valerie Uvin, MD
Contact
valerieuvin@hotmail.com
Michael De Brucker, MD PHD
principal investigator · UZ Brussels

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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