Clinical trial NCT04487639: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sperm Preservation in Oncological Patients
Fertility
Cryopreservation
Keywords: Fertility preservation
Sperm
Cancer
COVID-19
SARS-CoV-2
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: Agence de La Biomédecine
First posted: 2020-07-27
Enrollment: 129
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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

Primary outcomes:
measure: Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
timeFrame: Semen collection day (Day0)
Secondary outcomes:
measure: To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate
timeFrame: Semen collection day (Day0)
measure: To determine if the presence of this virus in sperm is associated with its presence in nasal swabs
timeFrame: Semen collection day (Day0)
measure: To determine if the presence of this virus in sperm is associated with COVID symptoms
timeFrame: Semen collection day (Day0)
measure: To determine if the presence of this virus in sperm is associated with specific serological profiles
timeFrame: Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)
measure: To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments
timeFrame: Semen collection day (Day0)
measure: To determine if the presence of this virus in sperm could impair its quality
timeFrame: Semen collection day (Day0)
Other outcomes:
Locations:
city: Bondy
country: France
facility: AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction
city: Clamart
country: France
facility: AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Laboratoire de Virologie
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
city: Dijon
country: France
facility: CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS
city: Grenoble
country: France
facility: CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS
city: Lyon
country: France
facility: Hospices Civils de Lyon - Service AMP-CECOS
city: Marseille
country: France
facility: Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS
city: Nancy
country: France
facility: CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS
city: Paris
country: France
facility: AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS
city: Paris
country: France
facility: AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction
city: Poissy
country: France
facility: Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye
city: Reims
country: France
facility: CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims
city: Rouen
country: France
facility: CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS
city: Strasbourg
country: France
facility: CHU de Strasbourg - Service de Biologie de la reproduction
city: Toulouse
country: France
facility: CHU de Toulouse - CECOS Midi-Pyrénées
Study officials:
affiliation: CHU de Clermont-Ferrand
name: Florence BRUGNON, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: