Pilot Study to Detect SARS-CoV-2 Virus in Sperm

Covid19 Clinical Trial

— COVSPERM  

Official title:

Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04584593
• Other study ID #: RC31/20/0202
• Secondary ID: 2020-A01610-39
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2020
• Est. completion date: February 2022

Study information

• Verified date: November 2020
• Source: University Hospital, Toulouse
• Contact: Louis BUJAN, PR
• Phone: 05 67 77 10 41
• Email: bujan.l[@]chu-toulouse.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 2022
• Est. primary completion date: February 2022
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Patient aged 18 to 50, male.

• 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 having previously consulted for male infertility or having previously carried out a semen examination which was abnormal (WHO standard)

• 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.

Related Conditions & MeSH terms

• Covid19

Intervention

Biological:
• Sample
Men will give semen, saliva, nasopharyngeal, urine and blood specimens

Locations

Country	Name	City	State
France	University Hospital Toulouse	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

References & Publications (4)

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. — View Citation

Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Berri M, Gauger PC, Pozzi N, Authié 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. — View Citation

Gallien S, Moro A, Lediguerher G, Catinot V, Paboeuf F, Bigault L, Gauger PC, Pozzi N, Berri M, Authié 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SARS-CoV-2 genomic RNA in patient sperm	Search for presence of SARS-CoV-2 genomic RNA in patients sperm when they are in the acute phase of the infection with reverse transcriptase polymerase chain reaction	3 month
Secondary	SARS-CoV-2 location in patient sperm	Search of location of SARS-Cov-2 in patient sperm after centrifugation	3 month