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

Unknown status
Sperm Preservation in Oncological Patients
Fertility
Cryopreservation

Diagnostic Test: SARS-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

Eligibility 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

Eligibility Gender
Male
Eligibility Age
Minimum: 18 Years ~ Maximum: 60 Years
Countries
France
Locations

AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction
Bondy, France

AP-Hôpitaux de Paris - Hôpital Antoine Béclére - 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 à la Procréation CECOS
Grenoble, France

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

Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS
Marseille, France

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

AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS
Paris, France

AP-Hôpitaux de Paris - Hôpital 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-Pyrénées
Toulouse, France

Contacts

Lise LACLAUTRE, Pharm D
04 73 754 963 - 33
promo_interne_drci@chu-clermontferrand.fr

Florence BRUGNON, MD, PhD, Principal Investigator
CHU de Clermont-Ferrand

Agence de La Biomédecine
NCT Number
Keywords
Fertility preservation
Sperm
cancer
Covid-19
SARS-CoV-2