Detection of SARS-CoV-2 in Semen of COVID-19 Positive Males
COVIDSPERM
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable covid19
Started Aug 2020
Typical duration for not_applicable covid19
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedStudy Start
First participant enrolled
August 31, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2021
CompletedOctober 28, 2020
May 1, 2020
1 year
May 13, 2020
October 26, 2020
Conditions
Outcome Measures
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
within 7 days after positive testing for SARS-CoV-2
Secondary Outcomes (7)
duration of SARS-CoV-2 presence in semen
from first positive semen testing until first negative semen testing, upto 15 weeks
semen viscosity
from first until last semen analysis, upto 15 weeks
semen volume
from first until last semen analysis, upto 15 weeks
semen pH
from first until last semen analysis, upto 15 weeks
Sperm motility
from first until last semen analysis, upto 15 weeks
- +2 more secondary outcomes
Study Arms (1)
SARS-CoV-2 positive men
EXPERIMENTALMen who are tested positive for SARS-CoV-2 by PCR testing on nasopharyngeal swab.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Male
- PCR on nasopharyngeal swab positive for SARS-CoV-2
- Age: ≥ 18y - ≤ 50y
- Signed informed consent
- When undergoing ART treatment: ICSI treatment
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Brussel
Brussels, 1090, Belgium
Related Publications (1)
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.
PMID: 32379329RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael De Brucker, MD PHD
UZ Brussels
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 18, 2020
Study Start
August 31, 2020
Primary Completion
August 31, 2021
Study Completion
August 31, 2021
Last Updated
October 28, 2020
Record last verified: 2020-05
Data Sharing
- IPD Sharing
- Will not share