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

Fertility Clinical Trial

— FERTICOVID  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04487639
• Other study ID #: RNI 2020 BRUGNON
• Secondary ID: 2020-A01409-30
• Status: Completed
• Phase: N/A
• Start date: July 10, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: February 2024
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 129
• Est. completion date: December 31, 2023
• Est. primary completion date: July 2, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Cryopreservation
• Fertility
• Sperm Preservation in Oncological Patients

Intervention

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

Locations

Country	Name	City	State
France	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	Clermont-Ferrand
France	CHU de Clermont-Ferrand - Laboratoire de Virologie	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 Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction	Paris
France	AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS	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

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	Agence de La Biomédecine

Country where clinical trial is conducted

France, 

Outcome

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