Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients ?
Keywords
Abstract
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.
Dates
| Last Verified: | 06/30/2020 |
| First Submitted: | 07/20/2020 |
| Estimated Enrollment Submitted: | 07/22/2020 |
| First Posted: | 07/26/2020 |
| Last Update Submitted: | 07/22/2020 |
| Last Update Posted: | 07/26/2020 |
| Actual Study Start Date: | 07/09/2020 |
| Estimated Primary Completion Date: | 06/30/2021 |
| Estimated Study Completion Date: | 06/30/2021 |
Condition or disease
Intervention/treatment
Diagnostic Test: Cohort : patients needing oncofertility preservation
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Cohort : patients needing oncofertility preservation | Diagnostic Test: Cohort : patients needing oncofertility preservation 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 |
Eligibility Criteria
| Ages Eligible for Study | 18 Years To 18 Years |
| Sexes Eligible for Study | Male |
| Accepts Healthy Volunteers | Yes |
| Criteria | 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 |
Outcome
Primary Outcome Measures
1. Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR [Semen collection day (Day0)]
Secondary Outcome Measures
1. To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate [Semen collection day (Day0)]
2. To determine if the presence of this virus in sperm is associated with its presence in nasal swabs [Semen collection day (Day0)]
3. To determine if the presence of this virus in sperm is associated with COVID symptoms [Semen collection day (Day0)]
4. 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)]
5. To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments [Semen collection day (Day0)]
6. To determine if the presence of this virus in sperm could impair its quality [Semen collection day (Day0)]
