<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04487639</url>
  </required_header>
  <id_info>
    <org_study_id>RNI 2020 BRUGNON</org_study_id>
    <secondary_id>2020-A01409-30</secondary_id>
    <nct_id>NCT04487639</nct_id>
  </id_info>
  <brief_title>Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients ?</brief_title>
  <acronym>FERTICOVID</acronym>
  <official_title>Presence of SARS-CoV-2 in Semen: Impact on Fertility Preservation in Male Oncological Patients During the COVID-19 Pandemic ?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Clermont-Ferrand</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Agence de La Biomédecine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Clermont-Ferrand</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      During the COVID-19 pandemic, the French Agency of Biomedicine has recommended maintaining&#xD;
      fertility preservation for patients requiring immediate oncological treatments exhibiting&#xD;
      gonadotoxic effects. However, no study has examined the presence of SARS-CoV-2 in sperm from&#xD;
      cancer patients. This study aims therefore to detect the presence of SARS-CoV-2, specifically&#xD;
      in the seminal fluid and the spermatozoa fractions of cancer patient semen. The investigators&#xD;
      will determine if the virus presence in sperm is associated with its presence in the nasal&#xD;
      swabs, COVID symptoms, specific serological profiles and particular oncological&#xD;
      pathologies/treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To perform this, all patient undergoing oncological fertility preservation will be evaluated&#xD;
      for COVID-19 symptomatology (fever, cough, headache, myalgia, diarrhea, anosmia,&#xD;
      pharyngodynia). In addition, a nasopharyngeal swab for SARS-CoV-2 research by RT- qPCR will&#xD;
      be performed on the day of semen collection. On the same day, serological tests will be&#xD;
      carried out, and 30 to 50 days after, according to HAS specifications with methods validated&#xD;
      by the National Reference Center. Seminal fluid and spermatozoa will be separated by density&#xD;
      gradient centrifugation for a posteriori molecular analysis of SARS-CoV-2 presence.&#xD;
&#xD;
      Will thus be measured, within the same ejaculate, the concordance between the presence of&#xD;
      SARS-CoV-2 in the seminal fluid and in the sperm cells fraction.&#xD;
&#xD;
      The investigators will also determine if the virus presence in the sperm is related with :&#xD;
&#xD;
        -  (i) the presence of SARS-CoV-2 in the nasal swab;&#xD;
&#xD;
        -  (ii) patient symptomatology;&#xD;
&#xD;
        -  (iii) a specific serological profile;&#xD;
&#xD;
        -  (iv) a particular oncological pathology and / or treatment. The investigators may also&#xD;
           find out if the presence of the SARS-CoV-2 in semen affects sperm quality.&#xD;
&#xD;
      This study will be the first one examining the presence of SARS-CoV-2 in semen from cancer&#xD;
      patients. This will guarantee the safety of fertility preservation procedures during the&#xD;
      COVID-19 pandemic.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 10, 2020</start_date>
  <completion_date type="Anticipated">July 2021</completion_date>
  <primary_completion_date type="Anticipated">July 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if the presence of this virus in sperm is associated with its presence in nasal swabs</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if the presence of this virus in sperm is associated with COVID symptoms</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if the presence of this virus in sperm is associated with specific serological profiles</measure>
    <time_frame>Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To determine if the presence of this virus in sperm could impair its quality</measure>
    <time_frame>Semen collection day (Day0)</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Sperm Preservation in Oncological Patients</condition>
  <condition>Fertility</condition>
  <condition>Cryopreservation</condition>
  <arm_group>
    <arm_group_label>Cohort : patients needing oncofertility preservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics</intervention_name>
    <description>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</description>
    <arm_group_label>Cohort : patients needing oncofertility preservation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Man above 18 years of age, of reproductive age, needing oncofertility preservation&#xD;
             through spermatozoa cryopreservation prior to a putative gonadotoxic treatment during&#xD;
             the COVID-19 pandemic.&#xD;
&#xD;
          -  Symptomatic and asymptomatic COVID-19 patients. A patient is considered as symptomatic&#xD;
             if he presents one or several of the following clinical signs: fever, cough,&#xD;
             cephalalgia, myalgia, diarrhea, anosmia, pharyngodynia.&#xD;
&#xD;
          -  A sufficient number of remaining spermatozoa straws to perform at least six ART&#xD;
             attempts&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Azoospermia&#xD;
&#xD;
          -  Severe Oligo-Astheno-Teratozoospermia (OAT) or Cryptozoospermia&#xD;
&#xD;
          -  Semen collection failure&#xD;
&#xD;
          -  Non-emergency fertility preservation or treatment with low gonadotoxic risk&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Florence BRUGNON, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Clermont-Ferrand</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lise LACLAUTRE, Pharm D</last_name>
    <phone>04 73 754 963</phone>
    <phone_ext>33</phone_ext>
    <email>promo_interne_drci@chu-clermontferrand.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>AP-Hôpitaux de Paris - Hôpital Jean Verdier - Service de Biologie de la reproduction</name>
      <address>
        <city>Bondy</city>
        <zip>93140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Florence EUSTACHE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Florence EUSTACHE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Solmaz SARANDI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Badria BENNANI SMIRES, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AP-Hôpitaux de Paris - Hôpital Antoine Béclére - Service de Biologie de la reproduction et AMP DPI CECOS</name>
      <address>
        <city>Clamart</city>
        <zip>92140</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nelly FRYDMAN, PharmD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Nelly FRYDMAN, PharmD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Olivier BINOIS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne MAYEUR, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laëtitia HESTERS, PharmD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand - Laboratoire de Virologie</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Cécile HENQUELL, PharmD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Cécile HENQUELL, PharmD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Amélie BREBION, PharmD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Audrey MIRAND, PharmD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Clermont-Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <zip>63000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Florence BRUGNON, MD, PhD</last_name>
      <phone>04 73 750 231</phone>
      <phone_ext>33</phone_ext>
      <email>fbrugnon@chu-clermontferrand.fr</email>
    </contact>
    <contact_backup>
      <last_name>Hanae Pons-Rejraji, PhD</last_name>
      <phone>04 73 75 02 31</phone>
      <phone_ext>33</phone_ext>
      <email>hpons-rejraji@chu-clermontferrand.fr</email>
    </contact_backup>
    <investigator>
      <last_name>Florence BRUGNON, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laure CHAPUT, PD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Solène VORILHON, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon - Laboratoire de Biologie de la Reproduction-CECOS</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Patricia FAUQUE, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Patricia FAUQUE, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Céline BRUNO, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julie BARBERET, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Sara KOUIRI, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Grenoble - Laboratoire d'Aide à la Procréation CECOS</name>
      <address>
        <city>Grenoble</city>
        <zip>38000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sylvianne HENNEBICQU, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Sylvianne HENNEBICQU, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Julien BESSONAT, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charlotte MAUROY, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Thomas BOUEILH, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Service AMP-CECOS</name>
      <address>
        <city>Lyon</city>
        <zip>69000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Sandrine GISCARD D'ESTAING, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Sandrine GISCARD D'ESTAING, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacqueline LORNAGE, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Elsa LABRUNE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital de la Conception - AP-Hôpitaux de Marseille - Service AMP-CECOS</name>
      <address>
        <city>Marseille</city>
        <zip>13000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Catherine GUILLEMAIN, MD</last_name>
    </contact>
    <investigator>
      <last_name>Catherine GUILLEMAIN, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jacqueline SAIAS-MAGNAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carole Carole, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy - Laboratoire de biologie de la reproduction - CECOS</name>
      <address>
        <city>Nancy</city>
        <zip>54000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Catherine DILIGENT, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Catherine DILIGENT, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle KOSCINSKI, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Caroline AIMONE VIANNA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AP-Hôpitaux de Paris - Hôpital Tenon - Service de Biologie de la reproduction - CECOS</name>
      <address>
        <city>Paris</city>
        <zip>75000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Rachel LEVY, MD</last_name>
    </contact>
    <investigator>
      <last_name>Rachel LEVY, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Charlotte DUPONT, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Rahaf HAJ HAMID, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AP-Hôpitaux de Paris - Hôpital Cochin - Service d'Histologie-Embryologie-Biologie de la reproduction</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Catherine PATRAT, MD</last_name>
    </contact>
    <investigator>
      <last_name>Catherine PATRAT, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Emmanuel DULIOUST, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Céline CHALAS, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Véronique DROUINEAUD, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Virginie BARRAUD-LANGE, MD, PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Diane RIVET-DANON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier intercommunal (CHI) de Poissy Saint Germain en Laye</name>
      <address>
        <city>Poissy</city>
        <zip>78300</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Florence BOITRELLE, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Florence BOITRELLE, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marion BENDAYAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Reims - Service de Biologie de la Reproduction - CECOS Champagne-Ardenne de Reims</name>
      <address>
        <city>Reims</city>
        <zip>51000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Béatrice DELEPINE, MD</last_name>
    </contact>
    <investigator>
      <last_name>Béatrice DELEPINE, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Anne-Sophie CANEPA, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Céline BOUILLON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen Normandie - Service Biologie de la Reproduction-CECOS</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nathalie RIVES, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nathalie RIVES, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Aurélie RIVES-FERAILLE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Pierre DI PIZIO, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Fanny JUMEAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg - Service de Biologie de la reproduction</name>
      <address>
        <city>Strasbourg</city>
        <zip>67000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Marius TELETIN, MD, PhD</last_name>
    </contact>
    <investigator>
      <last_name>Marius TELETIN, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Isabelle LICHTBLAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Laetitia LADUREAU-FRITSCH, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cécile GREZE, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Arthur LUTON, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse - CECOS Midi-Pyrénées</name>
      <address>
        <city>Toulouse</city>
        <zip>31000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nathalie MOINARD, MD</last_name>
    </contact>
    <investigator>
      <last_name>Nathalie MOINARD, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Louis BUJAN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Myriam DAUDIN, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jessika MOREAU, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 21, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>July 23, 2020</last_update_submitted>
  <last_update_submitted_qc>July 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Fertility preservation</keyword>
  <keyword>Sperm</keyword>
  <keyword>Cancer</keyword>
  <keyword>COVID-19</keyword>
  <keyword>SARS-CoV-2</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04487639
org study id: RNI 2020 BRUGNON
secondary id: 2020-A01409-30
nct id: NCT04487639
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Detection of SARS-CoV-2 in sperm during fertility preservation procedures by RT-qPCR
time frame: Semen collection day (Day0)
description: 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.
measure: To correlate the presence of SARS-CoV-2 in the seminal fluid and the spermatozoa fractions of the same ejaculate
time frame: Semen collection day (Day0)
description: We will compare SARS-CoV-2 RT-PCR results of seminal fluid and the spermatozoa fractions of the same ejaculate
measure: To determine if the presence of this virus in sperm is associated with its presence in nasal swabs
time frame: Semen collection day (Day0)
description: we will correlate the SARS-CoV-2 detection (using RT- qPCR) in nasopharyngeal swab, seminal fluid and spermatozoa fractions
measure: To determine if the presence of this virus in sperm is associated with COVID symptoms
time frame: Semen collection day (Day0)
description: 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
measure: To determine if the presence of this virus in sperm is associated with specific serological profiles
time frame: Semen collection day (Day0) and 30 to 50 days after (Day 30 to 50)
description: 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
measure: To determine if the presence of this virus in sperm is associated with particular oncological pathologies/treatments
time frame: Semen collection day (Day0)
description: We will correlate the SARS-CoV-2 detection in seminal fluid and spermatozoa fractions with patient's oncological pathologies and treatments
measure: To determine if the presence of this virus in sperm could impair its quality
time frame: Semen collection day (Day0)
description: 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
arm group label: Cohort : patients needing oncofertility preservation
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: SARS-CoV-2 research in nasopharyngeal swab, sperm and serologics
description: 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
arm group label: Cohort : patients needing oncofertility preservation
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Florence BRUGNON, MD, PhD
role: Principal Investigator
affiliation: CHU de Clermont-Ferrand
last name: Lise LACLAUTRE, Pharm D
phone: 04 73 754 963
phone ext: 33
email: promo_interne_drci@chu-clermontferrand.fr
facility: 
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country: France
responsible party type: Sponsor
sharing ipd: No