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

October 26, 2020 updated by: Universitair Ziekenhuis Brussel
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.

Study Overview

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 Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 48 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SARS-CoV-2 positive men
Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
detection of SARS-CoV-2 in the semen
Time Frame: 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
within 7 days after positive testing for SARS-CoV-2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
duration of SARS-CoV-2 presence in semen
Time Frame: 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
from first positive semen testing until first negative semen testing, upto 15 weeks
semen viscosity
Time Frame: from first until last semen analysis, upto 15 weeks
viscosity of semen will be assessed macroscopically
from first until last semen analysis, upto 15 weeks
semen volume
Time Frame: from first until last semen analysis, upto 15 weeks
semen volume
from first until last semen analysis, upto 15 weeks
semen pH
Time Frame: from first until last semen analysis, upto 15 weeks
semen pH
from first until last semen analysis, upto 15 weeks
Sperm motility
Time Frame: from first until last semen analysis, upto 15 weeks
Sperm motility assesment, according to the WHO guidelines of 2010
from first until last semen analysis, upto 15 weeks
Sperm morphology
Time Frame: from first until last semen analysis, upto 15 weeks
Sperm morphology assesment, according to the WHO guidelines of 2010
from first until last semen analysis, upto 15 weeks
Sperm density
Time Frame: from first until last semen analysis, upto 15 weeks
Sperm density assesment, according to the WHO guidelines of 2010
from first until last semen analysis, upto 15 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Michael De Brucker, MD PHD, UZ Brussels

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 31, 2020

Primary Completion (Anticipated)

August 31, 2021

Study Completion (Anticipated)

August 31, 2021

Study Registration Dates

First Submitted

May 13, 2020

First Submitted That Met QC Criteria

May 15, 2020

First Posted (Actual)

May 18, 2020

Study Record Updates

Last Update Posted (Actual)

October 28, 2020

Last Update Submitted That Met QC Criteria

October 26, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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