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
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