Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2020-A01409-30 | Other Identifier | ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Agence de La Biomédecine | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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.
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 :
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort : patients needing oncofertility preservation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics | Diagnostic Test | 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 |
| 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) |
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Florence BRUGNON, MD, PhD | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction | Bondy | 93140 | France | |||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
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) |
| AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS |
| Clamart |
| 92140 |
| France |
| CHU de Clermont-Ferrand - Laboratoire de Virologie | Clermont-Ferrand | 63000 | France |
| CHU de Clermont-Ferrand | Clermont-Ferrand | 63000 | France |
| CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS | Dijon | France |
| CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS | Grenoble | 38000 | France |
| Hospices Civils de Lyon - Service AMP-CECOS | Lyon | 69000 | France |
| Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS | Marseille | 13000 | France |
| CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS | Nancy | 54000 | France |
| AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS | Paris | 75000 | France |
| AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction | Paris | 75014 | France |
| Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye | Poissy | 78300 | France |
| CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims | Reims | 51000 | France |
| CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS | Rouen | 76000 | France |
| CHU de Strasbourg - Service de Biologie de la reproduction | Strasbourg | 67000 | France |
| CHU de Toulouse - CECOS Midi-Pyrénées | Toulouse | 31000 | France |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013076 | Sperm Count |
| ID | Term |
|---|---|
| D002452 | Cell Count |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D055101 | Semen Analysis |
| D008919 | Investigative Techniques |
| D002468 | Cell Physiological Phenomena |
Not provided
Not provided