Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2026-01-06 @ 10:41 AM
Study NCT ID:
NCT04584593
Status:
UNKNOWN
Last Update Posted:
2020-11-03
First Post:
2020-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study to Detect SARS-CoV-2 Virus in Sperm
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.
Status:
UNKNOWN
Status Verified Date:
2020-11
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COVSPERM
Brief Summary:
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
Detailed Description:
Since the end of 2019, an epidemic of SARS-CoV-2 infections (COVID-19) began in China and is now a global pandemic affecting more than 3 millions of people. Droplets and close contact are the most common routes of transmission of SARS-CoV-2 and aerosol transmission may be another route. Researchers have detected SARS-CoV-2 in samples of respiratory tract, saliva, stool, gastrointestinal tract, urine, tears and conjunctival secretions of COVID-19 patients.
Vertical transmission from mother to infant has been suspected, but not confirmed to date. Information about localization of SARS-CoV-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. One of two studies have reported SARS-CoV-2 RNA in semen from six infected patients. However, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa).
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
Vertical transmission from mother to infant has been suspected, but not confirmed to date. Information about localization of SARS-CoV-2 in the genital tract or shedding is poorly documented and the results of these studies were discrepant. One of two studies have reported SARS-CoV-2 RNA in semen from six infected patients. However, there is no data on the duration of the seminal excretion of the virus, its viral load and infectiousness and on its localization in semen compartments (cells, seminal plasma, spermatozoa).
The purpose of this study is to seek the presence of SARS-CoV-2 in semen, to determine its localization and infectiousness and to assess the efficiency of spermatozoa processing methods to obtain virus free spermatozoa.
This is a prospective study involving 50 patients, with acute SARS-CoV-2 infection and a positive RNA detection. Men will give semen, saliva, urine and blood specimens following RT-PCR diagnosis and 15, 30, 60 and 90 days after. SARS-CoV-2 RNA will be detected in seminal plasma, native semen cells and processed spermatozoa.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2020-A01610-39 | OTHER | ID-RCB | View |