Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
50 participants
INTERVENTIONAL
2020-10-02
2022-02-28
Brief Summary
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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
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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SARV-Cov
Men will give semen, saliva, urine and blood specimens
Sample
Men will give semen, saliva, nasopharyngeal, urine and blood specimens
Interventions
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Sample
Men will give semen, saliva, nasopharyngeal, urine and blood specimens
Eligibility Criteria
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Inclusion Criteria
* Patient in acute phase of infection with SARS-CoV-2 and whose RT-PCR shows the viral genome in the nasopharyngeal or salivary sample or in any other sample.
* Patient who can come to the laboratory for samples
* Patient having given his free and informed consent and having signed the consent
* Patient affiliated to a social security scheme or equivalent
Exclusion Criteria
* Patient with ejaculation disorder or unable to take a semen sample or with an abnormal semen volume (\<1.5 mL).
* Patient who would present serious clinical signs that would not allow him to travel to the investigating center to take samples.
* Patient under a protection regime for adults (including guardianship, curatorship or safeguard of justice.
18 Years
50 Years
MALE
No
Sponsors
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University Hospital, Toulouse
OTHER
Responsible Party
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Principal Investigators
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Louis BUJAN, PR
Role: PRINCIPAL_INVESTIGATOR
University Hospital, Toulouse
Locations
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University Hospital Toulouse
Toulouse, , France
Countries
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Central Contacts
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Facility Contacts
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Louis BUJAN, Pr
Role: primary
References
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Guan WJ, Ni ZY, Hu Y, Liang WH, Ou CQ, He JX, Liu L, Shan H, Lei CL, Hui DSC, Du B, Li LJ, Zeng G, Yuen KY, Chen RC, Tang CL, Wang T, Chen PY, Xiang J, Li SY, Wang JL, Liang ZJ, Peng YX, Wei L, Liu Y, Hu YH, Peng P, Wang JM, Liu JY, Chen Z, Li G, Zheng ZJ, Qiu SQ, Luo J, Ye CJ, Zhu SY, Zhong NS; China Medical Treatment Expert Group for Covid-19. Clinical Characteristics of Coronavirus Disease 2019 in China. N Engl J Med. 2020 Apr 30;382(18):1708-1720. doi: 10.1056/NEJMoa2002032. Epub 2020 Feb 28.
Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Berri M, Gauger PC, Pozzi N, Authie E, Rose N, Grasland B. Evidence of porcine epidemic diarrhea virus (PEDV) shedding in semen from infected specific pathogen-free boars. Vet Res. 2018 Jan 24;49(1):7. doi: 10.1186/s13567-018-0505-2.
Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Gauger PC, Pozzi N, Berri M, Authie E, Rose N, Grasland B. Limited shedding of an S-InDel strain of porcine epidemic diarrhea virus (PEDV) in semen and questions regarding the infectivity of the detected virus. Vet Microbiol. 2019 Jan;228:20-25. doi: 10.1016/j.vetmic.2018.09.025. Epub 2018 Oct 11.
Baud D, Greub G, Favre G, Gengler C, Jaton K, Dubruc E, Pomar L. Second-Trimester Miscarriage in a Pregnant Woman With SARS-CoV-2 Infection. JAMA. 2020 Jun 2;323(21):2198-2200. doi: 10.1001/jama.2020.7233.
Other Identifiers
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2020-A01610-39
Identifier Type: OTHER
Identifier Source: secondary_id
RC31/20/0202
Identifier Type: -
Identifier Source: org_study_id