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

NCT ID: NCT04391829

Last Updated: 2020-10-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-31

Study Completion Date

2021-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COVID-19 Sars-CoV2 Corona Virus Infection Semen

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SARS-CoV-2 positive men

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

Group Type EXPERIMENTAL

Ejaculated semen sample

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Ejaculated 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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Universitair Ziekenhuis Brussel

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Michael De Brucker, MD PHD

Role: PRINCIPAL_INVESTIGATOR

UZ Brussels

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UZ Brussel

Brussels, , Belgium

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Belgium

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Michael De Brucker, MD PHD

Role: CONTACT

+32494455084

Valerie Uvin, MD

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

valerie uvin, md

Role: primary

486073292 ext. 0032

michael de brucker, md phd

Role: backup

494455084 ext. 0032

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 32379329 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

COVIDSPERM

Identifier Type: -

Identifier Source: org_study_id