<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/NCT02975245</url>
  </required_header>
  <id_info>
    <org_study_id>PRO12080254</org_study_id>
    <nct_id>NCT02975245</nct_id>
  </id_info>
  <brief_title>Short Term Genetic Effects of Chemotherapy on Male Germ Cells</brief_title>
  <official_title>Short Term Genetic Effects of Chemotherapy on Male Germ Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will determine the short-term effects of chemotherapy on sperm DNA.The study&#xD;
      involves the collection of semen sample through ejaculation prior to initiation of&#xD;
      chemotherapy and up to three time points after initiation of chemotherapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While medical advances in the area of cancer treatment have successfully improved the overall&#xD;
      detection and treatment of many cancers affecting men and women alike, these very treatment&#xD;
      modalities can adversely affect their reproductive capacity.&#xD;
&#xD;
      Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients&#xD;
      at high risk for infertility. For men, the best recommendation for patients undergoing such&#xD;
      therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may&#xD;
      not always occur. Some patients have been noted to present to discuss fertility preservation&#xD;
      options after completing their first cycle of chemotherapy. In this situation, they will most&#xD;
      likely still have sperm which was produced prior to chemotherapy that can be collected even&#xD;
      if the stem cells producing the sperm have been damaged or destroyed. However, there are no&#xD;
      national guidelines addressing this particular situation. Typically, physicians may advise&#xD;
      men to avoid conception anywhere from three months to two years after the final dose of&#xD;
      chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ&#xD;
      cells remain.&#xD;
&#xD;
      It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in&#xD;
      the short window of time between exposure and potential sterility. If a safe time frame could&#xD;
      be determined to collect sperm after a single dose of chemotherapy, then these men could be&#xD;
      given a second chance to retain their fertility potential.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">February 2026</completion_date>
  <primary_completion_date type="Anticipated">February 2026</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.</measure>
    <time_frame>5 years</time_frame>
    <description>Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.</measure>
    <time_frame>5 years</time_frame>
    <description>Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Men receiving chemotherapy</arm_group_label>
    <description>Semen collection and analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Semen collection and analysis</intervention_name>
    <description>Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.</description>
    <arm_group_label>Men receiving chemotherapy</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Semen sample&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Males between the ages of 18 and 50 who are scheduled to undergo chemotherapy for medical&#xD;
        indication.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Be scheduled to undergo treatment with chemotherapeutic agents for a medical&#xD;
             indication&#xD;
&#xD;
          -  Be able to produce semen samples prior to chemotherapy and one week after first round&#xD;
             of chemotherapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Men who have previously been treated with chemotherapeutic agents.&#xD;
&#xD;
          -  Men with significant oligospermia or azospermia.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</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>May 2023</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>May 22, 2023</last_update_submitted>
  <last_update_submitted_qc>May 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 23, 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>Male infertility</keyword>
  <keyword>Germ cells</keyword>
  <keyword>Chemotherapy</keyword>
  <keyword>Sperm</keyword>
  <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/NCT02975245
org study id: PRO12080254
nct id: NCT02975245
lead sponsor: 
has dmc: Yes
This study will determine the short-term effects of chemotherapy on sperm DNA.The study
      involves the collection of semen sample through ejaculation prior to initiation of
      chemotherapy and up to three time points after initiation of chemotherapy.
While medical advances in the area of cancer treatment have successfully improved the overall
      detection and treatment of many cancers affecting men and women alike, these very treatment
      modalities can adversely affect their reproductive capacity.

      Certain types of chemotherapy, such as alkylating agents, are notorious for placing patients
      at high risk for infertility. For men, the best recommendation for patients undergoing such
      therapy is to cryopreserve semen prior to initiation of chemotherapy. Unfortunately, this may
      not always occur. Some patients have been noted to present to discuss fertility preservation
      options after completing their first cycle of chemotherapy. In this situation, they will most
      likely still have sperm which was produced prior to chemotherapy that can be collected even
      if the stem cells producing the sperm have been damaged or destroyed. However, there are no
      national guidelines addressing this particular situation. Typically, physicians may advise
      men to avoid conception anywhere from three months to two years after the final dose of
      chemotherapy to ensure all exposed germ cells have passed through and only newly formed germ
      cells remain.

      It is crucial to further assess the effects of chemotherapeutic agents on male germ cells in
      the short window of time between exposure and potential sterility. If a safe time frame could
      be determined to collect sperm after a single dose of chemotherapy, then these men could be
      given a second chance to retain their fertility potential.
observational model: Cohort
time perspective: Prospective
measure: the differences in DNA between sperm collected before chemotherapy to sperm collected after the first round of chemotherapy using whole exome sequencing.
time frame: 5 years
description: Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
measure: changes in sperm quality from sperm collected before the initiation of chemotherapy to sperm collected after first round of chemotherapy using sperm count test.
time frame: 5 years
description: Sperm count test analyzes the health and viability of sperm, as it takes into account sperm number, motility, and morphology.
arm group label: Men receiving chemotherapy
description: Semen collection and analysis
intervention type: Procedure
intervention name: Semen collection and analysis
description: Semen sample will be collected prior to the initiation of chemotherapy and one week after the first round of chemotherapy.
arm group label: Men receiving chemotherapy
Semen sample
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 50 Years
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
sharing ipd: Undecided