Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 129
- 试验地点
- 16
- 主要终点
- Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
研究概览
简要总结
During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining fertility preservation for patients requiring immediate oncological treatments exhibiting gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators will determine if the virus presence in sperm is associated with its presence in the nasal swabs, COVID symptoms, specific serological profiles and particular oncological pathologies/treatments.
详细描述
To perform this, all patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will be performed on the day of semen collection. On the same day, serological tests will be carried out, and 30 to 50 days after, according to HAS specifications with methods validated by the National Reference Center. Seminal fluid and spermatozoa will be separated by density gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.
Will thus be measured, within the same ejaculate, the concordance between the presence of SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.
The investigators will also determine if the virus presence in the sperm is related with :
- (i) the presence of SARS-CoV-2 in the nasal swab;
- (ii) patient symptomatology;
- (iii) a specific serological profile;
- (iv) a particular oncological pathology and / or treatment. The investigators may also find out if the presence of the SARS-CoV-2 in semen affects sperm quality.
This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer patients. This will guarantee the safety of fertility preservation procedures during the COVID-19 pandemic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Man above 18 years of age, of reproductive age, needing oncofertility preservation through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during the COVID-19 pandemic.
- •Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic if he presents one or several of the following clinical signs: fever, cough, cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.
- •A sufficient number of remaining spermatozoa straws to perform at least six ART attempts
排除标准
- •Azoospermia
- •Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
- •Semen collection failure
- •Non-emergency fertility preservation or treatment with low gonadotoxic risk
研究组 & 干预措施
Cohort : patients needing oncofertility preservation
干预措施: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics (Diagnostic Test)
结局指标
主要结局
Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
时间窗: Semen collection day (Day0)
Seminal fluid and spermatozoa will be separated by density gradient centrifugation, and SARS-CoV-2 will be detected by RT-qPCR in the both fractions.
次要结局
- To determine if the presence of this virus in sperm is associated with its presence in nasal swabs(Semen collection day (Day0))
- To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments(Semen collection day (Day0))
- To determine if the presence of this virus in sperm is associated with COVID symptoms(Semen collection day (Day0))
- To determine if the presence of this virus in sperm is associated with specific serological profiles(Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50))
- To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate(Semen collection day (Day0))
- To determine if the presence of this virus in sperm could impair its quality(Semen collection day (Day0))