<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/NCT02972801</url>
  </required_header>
  <id_info>
    <org_study_id>PRO09120485</org_study_id>
    <nct_id>NCT02972801</nct_id>
  </id_info>
  <brief_title>Testicular Tissue Cryopreservation for Fertility Preservation</brief_title>
  <official_title>Testicular Tissue Cryopreservation for Fertility Preservation in Patients Facing Infertility-causing Diseases or Treatment Regimens</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Children's National Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital of Orange County</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ann &amp; Robert H Lurie Children's Hospital of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Medical College of Wisconsin</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Connecticut Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Nationwide Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Washington University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alfred I. duPont Hospital for Children</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Miami</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Chicago</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cook Children's Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Helen DeVos Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Seattle Children's Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Texas</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Oregon Health and Science University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Hackensack Meridian Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Indiana University Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Testicular tissue cryopreservation is an experimental procedure where a young boy's&#xD;
      testicular tissue is retrieved and frozen. This technique is reserved for young male patients&#xD;
      who are not yet producing mature sperm, with the ultimate goal that their tissue may be used&#xD;
      in the future to restore fertility when experimental techniques emerge from the research&#xD;
      pipeline.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Fertility status has an important impact on the post-treatment quality of life for cancer&#xD;
      survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow&#xD;
      transplantation). Semen cryopreservation is an established fertility preserving therapy, but&#xD;
      is not accessible or appropriate for all men. Currently there are no therapies to preserve&#xD;
      the future fertility of preadolescent boys. However, new reproductive therapies are under&#xD;
      development and may one day offer &quot;fertile hope&quot; to those survivors that do not currently&#xD;
      have access to fertility preserving therapies. Clinical management of fertility threatening&#xD;
      diseases and treatments must have foresight of the gonadotoxic side effects and the potential&#xD;
      for infertility. When no established fertility sparing options are available, it is&#xD;
      reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means&#xD;
      of fertility preservation.&#xD;
&#xD;
      This study will harvest testicular tissue from eligible patients. Separate portions of the&#xD;
      harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and&#xD;
      maintained for participating patients as a resource for future elective procedures to attempt&#xD;
      fertility restoration.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>January 2010</start_date>
  <completion_date type="Anticipated">January 2025</completion_date>
  <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of spermatogonial stem cells in the testicular tissue as determined by histology.</measure>
    <time_frame>5 years</time_frame>
    <description>A segment of testicular specimen (~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Cancer</condition>
  <condition>Autoimmune Disorders</condition>
  <arm_group>
    <arm_group_label>Testicular tissue biopsy</arm_group_label>
    <description>Testicular biopsy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Testicular biopsy</intervention_name>
    <description>Testicular biopsy is performed to obtain testicular tissue for cryopreservation</description>
    <arm_group_label>Testicular tissue biopsy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      testicular tissue&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Eligible patients who will undergo an infertility-causing treatment and for whom standard&#xD;
        of care fertility preservation procedures are not available will be identified by their&#xD;
        physician.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be male at any age.&#xD;
&#xD;
          -  Be scheduled to undergo surgery, chemotherapy, drug treatment and/or radiation for the&#xD;
             treatment or prevention of a medical condition or malignancy with risk of causing&#xD;
             permanent and complete loss of subsequent testicular function.&#xD;
&#xD;
          -  Or, have a medical condition or malignancy that requires removal of all or part of one&#xD;
             or both testicles.&#xD;
&#xD;
          -  Have newly diagnosed or recurrent disease. Those who were not enrolled at the time of&#xD;
             initial diagnosis (i.e., patients with recurrent disease) are eligible if they have&#xD;
             not previously received therapy that is viewed as likely to result in complete and&#xD;
             permanent loss of testicular function.&#xD;
&#xD;
          -  Have two testicles if undergoing elective removal of all or part of a testicle for&#xD;
             fertility preservation only. Note: removal of both testicles will limit fertility&#xD;
             preservation options.&#xD;
&#xD;
          -  Sign an approved informed consent and authorization permitting the release of personal&#xD;
             health information. The patient and/or the patient's legally authorized guardian must&#xD;
             acknowledge in writing that consent for specimen collection has been obtained, in&#xD;
             accordance with institutional policies approved by the U.S. Department of Health and&#xD;
&#xD;
          -  Consent for serum screening tests for infectious diseases [HIV-1, HIV-2, Hepatitis B,&#xD;
             Hepatitis C], to be performed at the time of testicular tissue harvesting.&#xD;
&#xD;
          -  Undergo a full history and physical examination and obtain standard pre-operative&#xD;
             clearance (based on the most recent ACC/AHA Guideline for Perioperative Cardiovascular&#xD;
             Evaluation for Noncardiac Surgery) as determined by their primary surgeon.&#xD;
&#xD;
          -  Participating in long term follow-up is a requirement of the protocol.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with psychological, psychiatric, or other conditions which prevent giving&#xD;
             fully informed consent.&#xD;
&#xD;
          -  Diagnosed with an underlying medical condition that significantly increases their risk&#xD;
             of complications from anesthesia and surgery.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kyle Orwig, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pittsburgh/University of Pittsburgh Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rachel Neelley</last_name>
    <phone>412-641-7475</phone>
    <phone_ext>1</phone_ext>
    <email>fertilitypreservation@upmc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>Magee-Womens Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rachel Neelley</last_name>
      <phone>412-641-7475</phone>
      <email>fertilitypreservation@upmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>October 12, 2016</study_first_submitted>
  <study_first_submitted_qc>November 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 23, 2016</study_first_posted>
  <last_update_submitted>December 22, 2022</last_update_submitted>
  <last_update_submitted_qc>December 22, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Kyle Orwig</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>Spermatogonial stem cells</keyword>
  <keyword>Testis</keyword>
  <keyword>Fertility</keyword>
  <keyword>Infertility</keyword>
  <keyword>Oncofertility</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.</ipd_time_frame>
    <ipd_access_criteria>De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.</ipd_access_criteria>
  </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/NCT02972801
org study id: PRO09120485
nct id: NCT02972801
lead sponsor: 
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has dmc: Yes
Testicular tissue cryopreservation is an experimental procedure where a young boy's
      testicular tissue is retrieved and frozen. This technique is reserved for young male patients
      who are not yet producing mature sperm, with the ultimate goal that their tissue may be used
      in the future to restore fertility when experimental techniques emerge from the research
      pipeline.
Fertility status has an important impact on the post-treatment quality of life for cancer
      survivors and other patients that receive gonadotoxic therapies (e.g., prior to bone marrow
      transplantation). Semen cryopreservation is an established fertility preserving therapy, but
      is not accessible or appropriate for all men. Currently there are no therapies to preserve
      the future fertility of preadolescent boys. However, new reproductive therapies are under
      development and may one day offer "fertile hope" to those survivors that do not currently
      have access to fertility preserving therapies. Clinical management of fertility threatening
      diseases and treatments must have foresight of the gonadotoxic side effects and the potential
      for infertility. When no established fertility sparing options are available, it is
      reasonable to offer harvesting and cryopreservation of testicular tissue as a possible means
      of fertility preservation.

      This study will harvest testicular tissue from eligible patients. Separate portions of the
      harvested tissue and/or cells will be 1) designated for research and 2) cryopreserved and
      maintained for participating patients as a resource for future elective procedures to attempt
      fertility restoration.
observational model: Case-Only
time perspective: Prospective
measure: Presence of spermatogonial stem cells in the testicular tissue as determined by histology.
time frame: 5 years
description: A segment of testicular specimen (~5%) will be removed and assessed for presence of spermatogonial stem cells by immunofluorescence and hematoxylin staining
arm group label: Testicular tissue biopsy
description: Testicular biopsy
intervention type: Procedure
intervention name: Testicular biopsy
description: Testicular biopsy is performed to obtain testicular tissue for cryopreservation
arm group label: Testicular tissue biopsy
testicular tissue
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kyle Orwig, PhD
role: Principal Investigator
affiliation: University of Pittsburgh/University of Pittsburgh Medical Center
last name: Rachel Neelley
phone: 412-641-7475
phone ext: 1
email: fertilitypreservation@upmc.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Kyle Orwig
investigator title: Professor
mesh term: Autoimmune Diseases
sharing ipd: Yes
ipd description: The investigators will publish individual participant data. The investigators will also report each individual participants data back to them. Participants will be identified with unique ID numbers. No identifiable information will be shared.
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: We will share IPD with the patient (and only the patient) within one year of enrollment. We share study protocol and ICF with collaborating sites upon request. De-identified IDP is shared with collaborating sites annually.
ipd access criteria: De-identified research data will be shared with collaborators via e-mail, and with the broader scientific community via publication and presentations at national/international meetings.