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Spots Global Cancer Trial Database for Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

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Trial Identification

Brief Title: Presence of SARS-CoV-2 (COVID-19) in Semen: Impact on Fertility Preservation in Male Oncological Patients ?

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

Study ID: NCT04487639

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT

Sex: MALE

Healthy Volunteers: No

Locations

AP-H么pitaux de Paris - H么pital Jean Verdier - Service de Biologie de la reproduction, Bondy, , France

AP-H么pitaux de Paris - H么pital Antoine B茅cl茅re - Service de Biologie de la reproduction et AMP DPI CECOS, Clamart, , France

CHU de Clermont-Ferrand - Laboratoire de Virologie, Clermont-Ferrand, , France

CHU de Clermont-Ferrand, Clermont-Ferrand, , France

CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS, Dijon, , France

CHU de Grenoble - Laboratoire d'Aide 脿 la Procr茅ation CECOS, Grenoble, , France

Hospices Civils de Lyon - Service AMP-CECOS, Lyon, , France

H么pital de la Conception - AP-H么pitaux de Marseille - Service AMP-CECOS, Marseille, , France

CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS, Nancy, , France

AP-H么pitaux de Paris - H么pital Tenon - Service de Biologie de la reproduction - CECOS, Paris, , France

AP-H么pitaux de Paris - H么pital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction, Paris, , France

Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye, Poissy, , France

CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims, Reims, , France

CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS, Rouen, , France

CHU de Strasbourg - Service de Biologie de la reproduction, Strasbourg, , France

CHU de Toulouse - CECOS Midi-Pyr茅n茅es, Toulouse, , France

Contact Details

Name: Florence BRUGNON, MD, PhD

Affiliation: CHU de Clermont-Ferrand

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

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