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

Not Applicable

Completed

• Conditions: Sperm Preservation in Oncological Patients; Fertility; Cryopreservation
• Interventions: Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics

• Registration Number: NCT04487639
• Lead Sponsor: University Hospital, Clermont-Ferrand

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.

Study Timeline

• Study Start: 2020-07-10
• Study First Submitted: 2020-07-21
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-27
• Primary Completion: 2021-07-02
• Study Completion: 2023-12-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-15
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 129

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohort : patients needing oncofertility preservation	SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics	-

Primary Outcome Measures

Name	Time	Method
Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR	Semen collection day (Day0)	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.

Secondary Outcome Measures

Name	Time	Method
To determine if the presence of this virus in sperm is associated with its presence in nasal swabs	Semen collection day (Day0)	we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions
To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments	Semen collection day (Day0)	We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments
To determine if the presence of this virus in sperm is associated with COVID symptoms	Semen collection day (Day0)	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
To determine if the presence of this virus in sperm is associated with specific serological profiles	Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)	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
To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate	Semen collection day (Day0)	We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate
To determine if the presence of this virus in sperm could impair its quality	Semen collection day (Day0)	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

Trial Locations

Locations (16)

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

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS; 🇫🇷 Dijon, France

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

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

CHU de Toulouse - CECOS Midi-Pyrénées; 🇫🇷 Toulouse, France

AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS; 🇫🇷 Clamart, France

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

CHU de Clermont-Ferrand - Laboratoire de Virologie; 🇫🇷 Clermont-Ferrand, France

CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS; 🇫🇷 Grenoble, France

Hospices Civils de Lyon - Service AMP-CECOS; 🇫🇷 Lyon, France

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

CHU de Strasbourg - Service de Biologie de la reproduction; 🇫🇷 Strasbourg, France

AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction; 🇫🇷 Paris, 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