<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/NCT01682525</url>
  </required_header>
  <id_info>
    <org_study_id>N09-454</org_study_id>
    <nct_id>NCT01682525</nct_id>
  </id_info>
  <brief_title>Ovarian Tissue Cryopreservation for Fertility Preservation</brief_title>
  <official_title>Ovarian Tissue Cryopreservation for Fertility Preservation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston IVF</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston IVF</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To provide a novel fertility preservation option for patients facing a fertility threatening&#xD;
      cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation&#xD;
      program. To determine if ovarian tissue cryopreservation provides women with a useful,&#xD;
      successful option for fertility preservation&#xD;
&#xD;
      The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an&#xD;
      alternative option for fertility preservation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Safety</measure>
    <time_frame>10 years</time_frame>
    <description>Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following:&#xD;
Minor: Local infection&#xD;
Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy</measure>
    <time_frame>10 years</time_frame>
    <description>Proportion of women who attempt pregnancy&#xD;
Proportion of women who become pregnant and outcome&#xD;
Proportion of women using assisted reproduction after re-implantation or ovarian tissue.&#xD;
Menstrual cyclicity and ovarian reserve in those with and without re-implantation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Ovarian tissue cryopreservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Frozen ovarian tissue</intervention_name>
    <description>Use of ovarian tissue cryopreserved and stored at Boston IVF</description>
    <arm_group_label>Ovarian tissue cryopreservation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment&#xD;
             or prevention of a medical condition or malignancy which are likely to result in&#xD;
             permanent loss of subsequent ovarian function or diminished fertility&#xD;
&#xD;
          -  Have a medical condition or malignancy that requires removal of all or part of one or&#xD;
             both ovaries&#xD;
&#xD;
          -  Patients may have newly diagnosed or recurrent disease&#xD;
&#xD;
          -  Be in good health so as to be able to undergo laparoscopic surgery as determined by&#xD;
             history and physical examinations, and consultation with the medical oncologist,&#xD;
             reproductive endocrinologist, surgeon and anesthesiologist&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Moderate to high-risk of ovarian failure due to treatment&#xD;
&#xD;
          -  Documented ovarian metastasis&#xD;
&#xD;
          -  HIV or hepatitis (B, C)-positive serology&#xD;
&#xD;
          -  Absolute surgical contraindications&#xD;
&#xD;
          -  ECOG performance status of 0 or 1&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Women with psychological, psychiatric, or other conditions which prevent giving fully&#xD;
             informed consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David Ryley, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston IVF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Newton Wellesley Hospital</name>
      <address>
        <city>Newton</city>
        <state>Massachusetts</state>
        <zip>02462</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Boston IVF</name>
      <address>
        <city>Waltham</city>
        <state>Massachusetts</state>
        <zip>02451</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.bostonivf.com</url>
    <description>Related Info</description>
  </link>
  <verification_date>February 2016</verification_date>
  <study_first_submitted>September 4, 2012</study_first_submitted>
  <study_first_submitted_qc>September 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 11, 2012</study_first_posted>
  <last_update_submitted>February 3, 2016</last_update_submitted>
  <last_update_submitted_qc>February 3, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston IVF</investigator_affiliation>
    <investigator_full_name>David Ryley, MD</investigator_full_name>
    <investigator_title>Reproductive Endocrinologist</investigator_title>
  </responsible_party>
  <keyword>Fertility preservation</keyword>
  <keyword>Ovarian Tissue</keyword>
  <keyword>Cryopreservation</keyword>
  <keyword>Assisted Reproductive Technology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <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/NCT01682525
org study id: N09-454
nct id: NCT01682525
lead sponsor: 
has dmc: No
To provide a novel fertility preservation option for patients facing a fertility threatening
      cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation
      program. To determine if ovarian tissue cryopreservation provides women with a useful,
      successful option for fertility preservation

      The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an
      alternative option for fertility preservation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Safety
time frame: 10 years
description: Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following:
Minor: Local infection
Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication
measure: Efficacy
time frame: 10 years
description: Proportion of women who attempt pregnancy
Proportion of women who become pregnant and outcome
Proportion of women using assisted reproduction after re-implantation or ovarian tissue.
Menstrual cyclicity and ovarian reserve in those with and without re-implantation
arm group label: Ovarian tissue cryopreservation
arm group type: Experimental
description: The ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue.
intervention type: Other
intervention name: Frozen ovarian tissue
description: Use of ovarian tissue cryopreserved and stored at Boston IVF
arm group label: Ovarian tissue cryopreservation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: David Ryley, MD
role: Principal Investigator
affiliation: Boston IVF
facility: 
facility: 
country: United States
url: http://www.bostonivf.com
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Boston IVF
investigator full name: David Ryley, MD
investigator title: Reproductive Endocrinologist
mesh term: Infertility
sharing ipd: No