xml: <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/NCT05997706</url>
    </required_header>
    <id_info>
      <org_study_id>2018/27AVR/196</org_study_id>
      <nct_id>NCT05997706</nct_id>
    </id_info>
    <brief_title>Unraveling the Klinefelter's Disease Physiopathology</brief_title>
    <acronym>KLINEFELTER</acronym>
    <official_title>Unraveling the Klinefelter's Disease Physiopathology by Organoid Model</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cliniques universitaires Saint-Luc- Université Catholique de Louvain</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>
        Organoid Model to unravel Klinefelter Syndrome infertility&#xD;
  &#xD;
        Klinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male&#xD;
        (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The&#xD;
        investigators will isolate and expand spermatogonial cells from KS patients, then using an&#xD;
        organoid model investigators will compare the behavior of these Spermatogonia from KS&#xD;
        patients when interacting with four combinations of somatic cell types incorporated in the&#xD;
        Extra Cellular Matrix hydrogel.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction)&#xD;
        for azoospermia.&#xD;
  &#xD;
        One extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells&#xD;
        isolation and culture.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2018</start_date>
    <completion_date type="Anticipated">April 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">April 1, 2025</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>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Klinefelter's infertility physiopathology</measure>
      <time_frame>Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.</time_frame>
      <description>Testicular biopsies will be digested using two steps enzymatic protocol. Cell suspensions will be in vitro cultured during 2 months. The following analyses will be performed: cells counts, cells characterisation by immunofluorescence and RTqPCR specific for the cell type, cells karyotypes.</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>Klinefelter Syndrome</condition>
    <condition>Infertility, Male</condition>
    <arm_group>
      <arm_group_label>Infertile patients</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Testicular biopsy</intervention_name>
      <description>Testicular biopsy is a clinical procedure for extraction of testicular tissue</description>
      <arm_group_label>Infertile patients</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Klinefelter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Mosaicism&#xD;
        </textblock>
      </criteria>
      <gender>Male</gender>
      <gender_based>Yes</gender_based>
      <minimum_age>5 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Christine Wyns, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cliniques Universitaires St Luc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Christine Wyns, MD, PhD</last_name>
      <phone>+3227649501</phone>
      <email>christine.wyns@uclouvain.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Maria Grazia Giudice, MD</last_name>
      <phone>+32485256903</phone>
      <email>maria.giudice@uclouvain.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Cliniques Universitaires St Luc</name>
        <address>
          <city>Brussels</city>
          <zip>1200</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Christine Wyns, MD,PhD</last_name>
      </contact>
      <investigator>
        <last_name>Christine Wyns, MD,PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 27, 2019</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 11, 2023</last_update_submitted>
    <last_update_submitted_qc>August 11, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Klinefelter Syndrome</keyword>
    <keyword>fertility preservation, male</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Klinefelter Syndrome</mesh_term>
      <mesh_term>Infertility, Male</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997706
  org study id: 2018/27AVR/196
  nct id: NCT05997706
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Organoid Model to unravel Klinefelter Syndrome infertility
  
        Klinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male
        (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The
        investigators will isolate and expand spermatogonial cells from KS patients, then using an
        organoid model investigators will compare the behavior of these Spermatogonia from KS
        patients when interacting with four combinations of somatic cell types incorporated in the
        Extra Cellular Matrix hydrogel.
  Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction)
        for azoospermia.
  
        One extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells
        isolation and culture.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Klinefelter's infertility physiopathology
  time frame: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.
  description: Testicular biopsies will be digested using two steps enzymatic protocol. Cell suspensions will be in vitro cultured during 2 months. The following analyses will be performed: cells counts, cells characterisation by immunofluorescence and RTqPCR specific for the cell type, cells karyotypes.
  arm group label: Infertile patients
  arm group type: Experimental
  description: Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels
  intervention type: Procedure
  intervention name: Testicular biopsy
  description: Testicular biopsy is a clinical procedure for extraction of testicular tissue
  arm group label: Infertile patients
  criteria: 
  gender: Male
  gender based: Yes
  minimum age: 5 Years
  maximum age: 50 Years
  healthy volunteers: No
  last name: Christine Wyns, MD, PhD
  role: Principal Investigator
  affiliation: Cliniques Universitaires St Luc
  last name: Christine Wyns, MD, PhD
  phone: +3227649501
  email: christine.wyns@uclouvain.be
  last name: Maria Grazia Giudice, MD
  phone: +32485256903
  email: maria.giudice@uclouvain.be
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor
  mesh term: Infertility
  mesh term: Klinefelter Syndrome
  mesh term: Infertility, Male
  sharing ipd: No