<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/NCT01696786</url>
  </required_header>
  <id_info>
    <org_study_id>0903010292</org_study_id>
    <nct_id>NCT01696786</nct_id>
  </id_info>
  <brief_title>Oocyte Cryopreservation</brief_title>
  <official_title>Oocyte Cryopreservation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Weill Medical College of Cornell University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Weill Medical College of Cornell University</source>
  <brief_summary>
    <textblock>
      The specific aim of this study is to further develop methods of oocyte cryopreservation and&#xD;
      evaluate their impact on reproductive outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2009</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2013</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>Survival rate of cryopreserved oocytes with each cryopreservation method</measure>
    <time_frame>1 year</time_frame>
    <description>Survival rate of cryopreserved oocytes with each cryopreservation method</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pregnancy rate following thawing/warming of oocytes</measure>
    <time_frame>1 year</time_frame>
    <description>Pregnancy rate following thawing/warming of oocytes</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Implantation rate per embryo transferred</measure>
    <time_frame>1 year</time_frame>
    <description>Implantation rate per embryo transferred</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">250</enrollment>
  <condition>Fertility Preservation</condition>
  <arm_group>
    <arm_group_label>Oocyte cryopreservation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Oocyte cryopreservation</intervention_name>
    <description>Oocyte (egg) cryopreservation (freezing) to preserve fertility</description>
    <arm_group_label>Oocyte cryopreservation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any consenting female who wishes to freeze unfertilized oocytes and are:&#xD;
&#xD;
          1. at risk for ovarian hyperstimulation syndrome (enlarged ovaries with abdominal fluid&#xD;
             accumulation) and postponement of pregnancy has been recommended.&#xD;
&#xD;
          2. a cancer patient anticipating treatment and have been cleared by the oncologists for&#xD;
             ovarian stimulation.&#xD;
&#xD;
          3. a female who seeks to preserve her future fertility and does not wish to use donor or&#xD;
             partner sperm to fertilize her eggs.&#xD;
&#xD;
          4. a donor egg recipient who elects to have some of the eggs obtained fertilized with&#xD;
             husband/partner sperm and the rest cryopreserved for future use.&#xD;
&#xD;
          5. a patient for whom the partner's sperm retrieval or production has failed and donor&#xD;
             sperm is not an option.&#xD;
&#xD;
          6. a patient who, for religious or ethical reasons, wants to limit the number of fresh&#xD;
             oocytes exposed to sperm (fertilization) and do not want to either discard or donate&#xD;
             the excess oocytes.&#xD;
&#xD;
        AND&#xD;
&#xD;
          1. has been clinically and psychologically approved for ovarian stimulation&#xD;
&#xD;
          2. age between 12 and 42 years, inclusive, at time of informed consent.&#xD;
&#xD;
          3. willing and able to comply with the protocol.&#xD;
&#xD;
          4. willing to provide follow-up information from her OB/GYN of any CVS/amniocentesis&#xD;
             results, as well as information on obstetrical outcome.&#xD;
&#xD;
          5. agree to undergo intracytoplasmic sperm injection (ICSI) when oocytes are thawed.&#xD;
&#xD;
        For cancer patients:&#xD;
&#xD;
          1. No significant ovarian pathology as judged by physical exam and radiological studies;&#xD;
&#xD;
          2. Patient's general condition and prognosis deemed favorable for surgery and chemo/radio&#xD;
             therapy;&#xD;
&#xD;
          3. No other major medical illness,&#xD;
&#xD;
          4. Oncologist approval for the ovarian stimulation and egg retrieval.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Age &gt; 42 Subjects who do not meet the inclusion criteria will be ineligible for&#xD;
        participation in this study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Weill Cornell Medical College</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 1, 2012</study_first_posted>
  <last_update_submitted>September 7, 2018</last_update_submitted>
  <last_update_submitted_qc>September 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01696786
org study id: 0903010292
nct id: NCT01696786
lead sponsor: 
The specific aim of this study is to further develop methods of oocyte cryopreservation and
      evaluate their impact on reproductive outcomes.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Survival rate of cryopreserved oocytes with each cryopreservation method
time frame: 1 year
description: Survival rate of cryopreserved oocytes with each cryopreservation method
measure: Pregnancy rate following thawing/warming of oocytes
time frame: 1 year
description: Pregnancy rate following thawing/warming of oocytes
measure: Implantation rate per embryo transferred
time frame: 1 year
description: Implantation rate per embryo transferred
arm group label: Oocyte cryopreservation
arm group type: Experimental
intervention type: Procedure
intervention name: Oocyte cryopreservation
description: Oocyte (egg) cryopreservation (freezing) to preserve fertility
arm group label: Oocyte cryopreservation
criteria: 
gender: Female
minimum age: N/A
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor