Pilot Study to Detect SARS-CoV-2 Virus in Sperm : a COVID-19 Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- SARS-CoV-2 genomic RNA in patient sperm
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
SARS-CoV-2 genomic RNA in patient sperm
时间窗: 3 month
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
次要结局
- SARS-CoV-2 location in patient sperm(3 month)