Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?

Conditions
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Sperm Preservation in Oncological Patients, Fertility, Cryopreservation

Intervention / Treatment
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* Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Azoospermia Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia Semen collection failure Non-emergency fertility preservation or treatment with low gonadotoxic risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort : patients needing oncofertility preservation<br> | Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR | 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. | Semen collection day (Day0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate | We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate | Semen collection day (Day0) | 
| To determine if the presence of this virus in sperm is associated with its presence in nasal swabs | we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions | Semen collection day (Day0) | 
| To determine if the presence of this virus in sperm is associated with COVID symptoms | Any patient undergoing oncological fertility preservation will be evaluated for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia, pharyngodynia). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with COVID symptoms | Semen collection day (Day0) | 
| To determine if the presence of this virus in sperm is associated with specific serological profiles | Serological tests (Sars-CoV2) will be carried out. We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with specific COVID serological profiles | Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50) | 
| To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments | We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments | Semen collection day (Day0) | 
| To determine if the presence of this virus in sperm could impair its quality | Before semen density gradient centrifugation and cryopreservation, standards sperm analysis will be performed according to the WHO guideline (2020). We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with standards sperm parameters | Semen collection day (Day0) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fertility preservation, Sperm, Cancer, COVID-19, SARS-CoV-2