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

NCT04487639 | Completed

• 2 other identifiers: RNI 2020 BRUGNON2020-A01409-30
• Study Type: interventional
• Target: 129
• Locations: 1 country
• Sites: 16

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.

Conditions

Sperm Preservation in Oncological Patients; Fertility; Cryopreservation

Keywords

Fertility preservation; Sperm; Cancer; COVID-19; SARS-CoV-2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• To correlate the presence of SARS-CoV-2 in the 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

  Semen collection day (Day0)

• To determine if the presence of this virus in sperm is associated with COVID symptoms

  Semen collection day (Day0)

• 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)

• To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments

  Semen collection day (Day0)

Study Arms (1)

Cohort : patients needing oncofertility preservation

EXPERIMENTAL

Diagnostic Test: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics

Interventions

SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics DIAGNOSTIC_TEST

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

Cohort : patients needing oncofertility preservation

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Azoospermia
• Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia
• Semen collection failure
• Non-emergency fertility preservation or treatment with low gonadotoxic risk

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead
• Agence de La Biomédecine: collaborator

Study Sites (16)

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

Bondy, 93140, France

Location

AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS

Clamart, 92140, France

Location

CHU de Clermont-Ferrand - Laboratoire de Virologie

Clermont-Ferrand, 63000, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, 63000, France

Location

CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS

Dijon, France

Location

CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS

Grenoble, 38000, France

Location

Hospices Civils de Lyon - Service AMP-CECOS

Lyon, 69000, France

Location

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

Marseille, 13000, France

Location

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

Nancy, 54000, France

Location

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

Paris, 75000, France

Location

AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction

Paris, 75014, France

Location

Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye

Poissy, 78300, France

Location

CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims

Reims, 51000, France

Location

CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS

Rouen, 76000, France

Location

CHU de Strasbourg - Service de Biologie de la reproduction

Strasbourg, 67000, France

Location

CHU de Toulouse - CECOS Midi-Pyrénées

Toulouse, 31000, France

Location

MeSH Terms

Conditions

Neoplasms; COVID-19

Interventions

Sperm Count

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Semen Analysis; Investigative Techniques; Cell Physiological Phenomena

Study Officials

• Florence BRUGNON, MD, PhD

  CHU de Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 27, 2020
• Study Start: July 10, 2020
• Primary Completion: July 2, 2021
• Study Completion: December 31, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)