COVID-19COVIDSPERMNCT04391829
Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males
A study testing Ejaculated semen sample in people with COVID-19 and Sars-CoV2, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 50 years, men only
- Conditions the study is for
- COVID-19, Sars-CoV2, Corona Virus Infection
- What is being tested?
- Ejaculated semen sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- 31 Aug 2020to 31 Aug 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male
- PCR on nasopharyngeal swab positive for SARS-CoV-2
- Age: ≥ 18y - ≤ 50y
- Signed informed consent
- When undergoing ART treatment: ICSI treatment
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Valerie Uvin, MD contact
Belgium1 site, 1 recruiting
- Recruiting
UZ Brussel
Brussels, 1090
valerie uvin, md, 486073292 ext. 0032, valerieuvin@hotmail.com
michael de brucker, md phd, 494455084 ext. 0032, michaeldebrucker@gmail.com
About this study
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.
- Conditions
- COVID-19, Sars-CoV2, Corona Virus Infection, Semen
- Being tested
- Ejaculated semen sample
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ejaculated semen sampleDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| SARS-CoV-2 positive men | Experimental | Men who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab. Receives: Diagnostic Test: Ejaculated semen sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: within 7 days after positive testing for SARS-CoV-2
Secondary outcomes (7)
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
Measured: from first positive semen testing until first negative semen testing, upto 15 weeks
semen viscosity
viscosity of semen will be assessed macroscopically
Measured: from first until last semen analysis, upto 15 weeks
semen volume
semen volume
Measured: from first until last semen analysis, upto 15 weeks
semen pH
semen pH
Measured: from first until last semen analysis, upto 15 weeks
Sperm motility
Sperm motility assesment, according to the WHO guidelines of 2010
Measured: from first until last semen analysis, upto 15 weeks
Sperm morphology
Sperm morphology assesment, according to the WHO guidelines of 2010
Measured: from first until last semen analysis, upto 15 weeks
Sperm density
Sperm density assesment, according to the WHO guidelines of 2010
Measured: from first until last semen analysis, upto 15 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start31 Aug 2020
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael De Brucker, MD PHD, Principal investigator, UZ Brussels
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391829
- Sponsor's protocol ID
- COVIDSPERM
- Acronym
- COVIDSPERM
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 28 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 32379329
Study at a glance
From the registry record, last updated by the sponsor on 28 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males
- ClinicalTrials.gov ID
- NCT04391829
- Acronym / sponsor ID
- COVIDSPERM / COVIDSPERM
- Conditions
- COVID-19, Sars-CoV2, Corona Virus Infection, Semen
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 31 Aug 2020 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SARS-CoV-2 positive men | Experimental | Diagnostic Test: Ejaculated semen sampleMen who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male
- PCR on nasopharyngeal swab positive for SARS-CoV-2
- Age: ≥ 18y - ≤ 50y
- Signed informed consent
- When undergoing ART treatment: ICSI treatment
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ejaculated semen sampleSARS-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. | Diagnostic test | SARS-CoV-2 positive men |
Primary outcome
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
7 secondary outcomes
duration of SARS-CoV-2 presence in semen
Time frame: 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
semen volume
Time frame: from first until last semen analysis, upto 15 weeks
semen pH
Time frame: from first until last semen analysis, upto 15 weeks
Sperm motility
Time frame: from first until last semen analysis, upto 15 weeks
Sperm morphology
Time frame: from first until last semen analysis, upto 15 weeks
Sperm density
Time frame: from first until last semen analysis, upto 15 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2020.
- Results publication: PubMed 32379329Li 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Valerie Uvin, MD contact
Michael De Brucker, MD PHD principal investigator
UZ Brussels
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ejaculated semen sample in people with COVID-19 and Sars-CoV2, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Michael De Brucker, MD PHD (+32494455084, michaeldebrucker@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
detection of SARS-CoV-2 in the semen (time frame: within 7 days after positive testing for SARS-CoV-2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04391829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2020.