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

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

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.

Study Overview

• Status: Completed
• Conditions: Fertility; Sperm Preservation in Oncological Patients; Cryopreservation
• Intervention / Treatment: Diagnostic test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics

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 Type: Interventional
• Enrollment (Actual): 129
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Reims, France, 51000
    • CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims
  • France
    • Bondy, France, France, 93140
      • AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction
    • Clamart, France, France, 92140
      • AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS
    • Clermont-Ferrand, France, France, 63000
      • CHU de Clermont-Ferrand
    • Clermont-Ferrand, France, France, 63000
      • CHU de Clermont-Ferrand - Laboratoire de Virologie
    • Dijon, France, France
      • CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS
    • Grenoble, France, France, 38000
      • CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS
    • Lyon, France, France, 69000
      • Hospices Civils de Lyon - Service AMP-CECOS
    • Marseille, France, France, 13000
      • Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS
    • Nancy, France, France, 54000
      • CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS
    • Paris, France, France, 75000
      • AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS
    • Paris, France, France, 75014
      • AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction
    • Poissy, France, France, 78300
      • Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye
    • Rouen, France, France, 76000
      • CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS
    • Strasbourg, France, France, 67000
      • CHU de Strasbourg - Service de Biologie de la reproduction
    • Toulouse, France, France, 31000
      • CHU de Toulouse - CECOS Midi-Pyrénées

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort : patients needing oncofertility preservation	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: University Hospital, Clermont-Ferrand
• Collaborators: Agence de La Biomédecine
• Investigators: Principal Investigator: Florence BRUGNON, MD, PhD, University Hospital, Clermont-Ferrand

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Actual): July 2, 2021
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: July 21, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 27, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 31, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Cancer; COVID-19; Fertility preservation; Sperm
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; COVID-19; Neoplasms; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Cell Count; Cytological Techniques; Cell Physiological Phenomena; Semen Analysis; Sperm Count
• Other Study ID Numbers: RNI 2020 BRUGNON; 2020-A01409-30 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No