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

Primary Purpose

COVID-19, Sars-CoV2, Corona Virus Infection

Status

Unknown status

Phase

Not Applicable

Locations

Belgium

Study Type

Interventional

Intervention

Ejaculated semen sample

About this trial

This is an interventional diagnostic trial for COVID-19

Eligibility Criteria

18 Years - 50 Years (Adult)MaleDoes not accept 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

Sites / Locations

UZ BrusselRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SARS-CoV-2 positive men

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

semen viscosity

viscosity of semen will be assessed macroscopically

semen volume

semen pH

Sperm motility

Sperm motility assesment, according to the WHO guidelines of 2010

Sperm morphology

Sperm morphology assesment, according to the WHO guidelines of 2010

Sperm density

Sperm density assesment, according to the WHO guidelines of 2010

Full Information

NCT ID

NCT04391829

First Posted

May 13, 2020

Last Updated

October 26, 2020

Sponsor

Universitair Ziekenhuis Brussel

1. Study Identification

Unique Protocol Identification Number

NCT04391829

Brief Title

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

Acronym

COVIDSPERM

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Unknown status

Study Start Date

August 31, 2020 (Actual)

Primary Completion Date

August 31, 2021 (Anticipated)

Study Completion Date

August 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universitair Ziekenhuis Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19, Sars-CoV2, Corona Virus Infection, Semen

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SARS-CoV-2 positive men

Arm Type

Experimental

Arm Description

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

Intervention Type

Diagnostic Test

Intervention Name(s)

Ejaculated semen sample

Intervention Description

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.

Primary Outcome Measure Information:

Title

detection of SARS-CoV-2 in the semen

Description

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 Outcome Measure Information:

Title

duration of SARS-CoV-2 presence in semen

Description

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

Title

semen viscosity

Description

viscosity of semen will be assessed macroscopically

Time Frame