Cryopreservation, Fertility, Sperm Preservation in Oncological Patients
Conditions
Keywords
Fertility preservation, Sperm, Cancer, COVID-19, SARS-CoV-2
Brief summary
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
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.
Interventions
DIAGNOSTIC_TESTSARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
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
Sponsors
University Hospital, Clermont-Ferrand
Agence de La Biomédecine
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate | Semen collection day (Day0) | We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate |
| To determine if the presence of this virus in sperm is associated with its presence in nasal swabs | Semen collection day (Day0) | we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions |
| To determine if the presence of this virus in sperm is associated with COVID symptoms | Semen collection day (Day0) | 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 |
| 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) | 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 |
| To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments | Semen collection day (Day0) | We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments |
| To determine if the presence of this virus in sperm could impair its quality | Semen collection day (Day0) | 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 |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORFlorence BRUGNON, MD, PhD
University Hospital, Clermont-Ferrand
Outcome results
None listed