<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/NCT03291522</url>
  </required_header>
  <id_info>
    <org_study_id>PRO17020423</org_study_id>
    <nct_id>NCT03291522</nct_id>
  </id_info>
  <brief_title>Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration</brief_title>
  <official_title>Retrieval of Sperm From Men With Azoospermia Using Ultrasound-guided Rete Testis Aspiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Infertility and IVF Center, St. Louis, MO</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</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>
      The objective of this study is to use ultrasound-guided rete testis flushing and aspiration&#xD;
      technique to retrieve sperm, non-surgically, from the testes of azoospermic men. If sperm are&#xD;
      retrieved by this method, it will provide a direct benefit to the infertile men. This&#xD;
      protocol will also establish the safety and feasibility of the ultrasound-guided rete testis&#xD;
      injection approach in consenting men before the approach is translated to teenage boys.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to demonstrate that ultrasound-guided rete testis aspiration is a&#xD;
      safe and effective method to flush and aspirate rare sperm from the testes of men with&#xD;
      azoospermia (no sperm in the ejaculate). Current methods to recover sperm from men with&#xD;
      azoospermia range from invasive and time consuming micro testicular sperm extraction&#xD;
      (microTESE) to fine needle aspiration (FNA), which is less invasive and less time consuming,&#xD;
      but also less effective because it is a blind approach. This approach is less invasive; it&#xD;
      involves the percutaneous insertion of a hypodermic needle into the rete testis space. This&#xD;
      approach is also not blind because the needle is accurately positioned under ultrasound&#xD;
      guidance into the rete testis space that is contiguous with all seminiferous tubules (where&#xD;
      sperm are made). The investigators will first perform the experimental ultrasound-guided rete&#xD;
      testis flushing and aspiration on both testis. If sperm is found, no standard of care&#xD;
      procedure (TESE, microTESE etc) will be performed. If sperm is not found, the participant can&#xD;
      choose whether or not to proceed with a standard of care procedure. In cases were&#xD;
      participants have previously tried a standard of care procedure, they may not want to do that&#xD;
      again if the experimental procedure does not work. For the ultrasound-guided rete testis&#xD;
      flushing and aspiration, the investigators will flush and aspirate the tubules with 500ul of&#xD;
      physiological saline and Optison ultrasound contrast agent in sterile 0.9% saline (routinely&#xD;
      used in clinics). Presence of sperm in the aspirate will be determined. The investigators&#xD;
      hypothesize that sperm recovery using the ultrasound-guided rete testis injection/aspiration&#xD;
      approach will at least as effective as the standard of care approach employed in the Magee&#xD;
      male fertility clinic and it will be less invasive.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 10, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2026</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 sperm</measure>
    <time_frame>5 years</time_frame>
    <description>Percentage of time that sperm is found with ultrasound-guided rete testis aspiration</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Azoospermia, Nonobstructive</condition>
  <condition>Infertility, Male</condition>
  <arm_group>
    <arm_group_label>Men with azoospermia</arm_group_label>
    <description>Ultrasound-guided rete testis flushing and aspiration</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound-guided rete testis flushing and aspiration</intervention_name>
    <description>Ultrasound-guided rete testis flushing and aspiration is performed first. If no sperm is found, the patient can choose to do a standard of care procedure (but not required).</description>
    <arm_group_label>Men with azoospermia</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Males over the age of 18 who are diagnosed with azoospermia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be a male over the age of 18&#xD;
&#xD;
          -  Be diagnosed with azoospermia&#xD;
&#xD;
          -  Have 2 testicles&#xD;
&#xD;
          -  Sign an approved consent and authorization permitting the release of personal health&#xD;
             information. The patient must acknowledge in writing that consent for sperm collection&#xD;
             has been obtained, in accordance with institutional policies approved by the U.S.&#xD;
             Department of Health and Human Services.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with psychological, psychiatric, or order conditions which prevent giving&#xD;
             fully informed consent&#xD;
&#xD;
          -  Diagnosed with underlying medical condition that significantly increases their risk of&#xD;
             complications from this procedure&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</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>
      <phone_ext>1</phone_ext>
      <email>fertilitypreservation@upmc.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>February 2, 2023</last_update_submitted>
  <last_update_submitted_qc>February 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 3, 2023</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>Testicular sperm extraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Azoospermia</mesh_term>
    <mesh_term>Infertility, Male</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03291522
org study id: PRO17020423
nct id: NCT03291522
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to use ultrasound-guided rete testis flushing and aspiration
      technique to retrieve sperm, non-surgically, from the testes of azoospermic men. If sperm are
      retrieved by this method, it will provide a direct benefit to the infertile men. This
      protocol will also establish the safety and feasibility of the ultrasound-guided rete testis
      injection approach in consenting men before the approach is translated to teenage boys.
The aim of this study is to demonstrate that ultrasound-guided rete testis aspiration is a
      safe and effective method to flush and aspirate rare sperm from the testes of men with
      azoospermia (no sperm in the ejaculate). Current methods to recover sperm from men with
      azoospermia range from invasive and time consuming micro testicular sperm extraction
      (microTESE) to fine needle aspiration (FNA), which is less invasive and less time consuming,
      but also less effective because it is a blind approach. This approach is less invasive; it
      involves the percutaneous insertion of a hypodermic needle into the rete testis space. This
      approach is also not blind because the needle is accurately positioned under ultrasound
      guidance into the rete testis space that is contiguous with all seminiferous tubules (where
      sperm are made). The investigators will first perform the experimental ultrasound-guided rete
      testis flushing and aspiration on both testis. If sperm is found, no standard of care
      procedure (TESE, microTESE etc) will be performed. If sperm is not found, the participant can
      choose whether or not to proceed with a standard of care procedure. In cases were
      participants have previously tried a standard of care procedure, they may not want to do that
      again if the experimental procedure does not work. For the ultrasound-guided rete testis
      flushing and aspiration, the investigators will flush and aspirate the tubules with 500ul of
      physiological saline and Optison ultrasound contrast agent in sterile 0.9% saline (routinely
      used in clinics). Presence of sperm in the aspirate will be determined. The investigators
      hypothesize that sperm recovery using the ultrasound-guided rete testis injection/aspiration
      approach will at least as effective as the standard of care approach employed in the Magee
      male fertility clinic and it will be less invasive.
observational model: Case-Only
time perspective: Prospective
measure: Presence of sperm
time frame: 5 years
description: Percentage of time that sperm is found with ultrasound-guided rete testis aspiration
arm group label: Men with azoospermia
description: Ultrasound-guided rete testis flushing and aspiration
intervention type: Procedure
intervention name: Ultrasound-guided rete testis flushing and aspiration
description: Ultrasound-guided rete testis flushing and aspiration is performed first. If no sperm is found, the patient can choose to do a standard of care procedure (but not required).
arm group label: Men with azoospermia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
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: Infertility
mesh term: Azoospermia
mesh term: Infertility, Male
sharing ipd: Undecided