<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/NCT01671657</url>
  </required_header>
  <id_info>
    <org_study_id>2012-AUX-008</org_study_id>
    <nct_id>NCT01671657</nct_id>
  </id_info>
  <brief_title>US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)</brief_title>
  <acronym>US EPIC</acronym>
  <official_title>US Eeva™ Pregnancy Investigational Clinical Study (US EPIC)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Progyny, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Progyny, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this clinical investigation is to gather data to evaluate the impact of using&#xD;
      Eeva with traditional morphology grading on implantation rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this clinical investigation is to gather data to evaluate the impact of&#xD;
      implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group)&#xD;
      versus Day 3 embryo transfers using morphology grading only (from a concurrent control&#xD;
      group).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2013</start_date>
  <completion_date type="Anticipated">June 2016</completion_date>
  <primary_completion_date type="Anticipated">June 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of implantation</measure>
    <time_frame>5-6 gestational age</time_frame>
    <description>To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate clinical pregnancy rates from the Eeva Test group to the Control group</measure>
    <time_frame>5-6 weeks gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>Gestational age week 8-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple pregnancy rate</measure>
    <time_frame>Gestational age weeks 5-6 and 8-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous miscarriage rate</measure>
    <time_frame>Gestational age week 8-12</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Eeva Test Group</arm_group_label>
    <description>Day 3 embryo transfers that used Eeva with morphology grading (Test Group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Matched case control group</arm_group_label>
    <description>Day 3 embryo transfers using morphology grading only (from concurrent Control Group).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing in vitro fertilization treatment who provide informed consent and plan&#xD;
        to undergo Day 3 embryo transfer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women undergoing fresh in vitro fertilization treatment using their own eggs or donor&#xD;
             eggs.&#xD;
&#xD;
          -  IVF cycle attempts ≤ 2.&#xD;
&#xD;
          -  Egg age ≤ 40 years.&#xD;
&#xD;
          -  Planned Day 3 embryo transfer.&#xD;
&#xD;
          -  At least 4 normally fertilized eggs (2PN).&#xD;
&#xD;
          -  All 2PN embryos must be imaged by Eeva.&#xD;
&#xD;
          -  Ejaculated sperm or sperm from the epididymis (fresh or frozen).&#xD;
&#xD;
          -  Willing to comply with study protocol and procedures.&#xD;
&#xD;
          -  Willing to provide written informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned preimplantation genetic diagnosis or preimplantation genetic screening.&#xD;
&#xD;
          -  Planned &quot;freeze all&quot; cycle (oocytes or embryos).&#xD;
&#xD;
          -  Sperm retrieved from testicular tissue.&#xD;
&#xD;
          -  Abnormal uterine cavity as evaluated by standard methods.&#xD;
&#xD;
          -  Gestational carrier.&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  Hydrosalpinx.&#xD;
&#xD;
          -  History of cancer.&#xD;
&#xD;
          -  Concurrent participation in another clinical study.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shehua Shen, MD, ELD</last_name>
    <role>Study Director</role>
    <affiliation>Progyny, Inc.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fertility Physicians of Northern California</name>
      <address>
        <city>San Jose</city>
        <state>California</state>
        <zip>95124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>October 19, 2015</last_update_submitted>
  <last_update_submitted_qc>October 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In vitro fertilization</keyword>
  <keyword>Assisted reproductive therapy</keyword>
  <keyword>Time-lapse image recording</keyword>
  <keyword>Image analysis software</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <!-- 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/NCT01671657
org study id: 2012-AUX-008
nct id: NCT01671657
lead sponsor: 
has dmc: No
The purpose of this clinical investigation is to gather data to evaluate the impact of using
      Eeva with traditional morphology grading on implantation rates.
The purpose of this clinical investigation is to gather data to evaluate the impact of
      implantation rates for Day 3 embryo transfers using Eeva and morphology grading (test group)
      versus Day 3 embryo transfers using morphology grading only (from a concurrent control
      group).
observational model: Case-Control
measure: Rate of implantation
time frame: 5-6 gestational age
description: To compare implantation rates for the Day 3 embryo transfers that used Eeva with morphology grading (test group) versus Day 3 embryo transfers using morphology grading only (control group).
measure: To evaluate clinical pregnancy rates from the Eeva Test group to the Control group
time frame: 5-6 weeks gestational age
measure: Ongoing pregnancy rate
time frame: Gestational age week 8-12
measure: Multiple pregnancy rate
time frame: Gestational age weeks 5-6 and 8-12
measure: Spontaneous miscarriage rate
time frame: Gestational age week 8-12
arm group label: Eeva Test Group
description: Day 3 embryo transfers that used Eeva with morphology grading (Test Group).
arm group label: Matched case control group
description: Day 3 embryo transfers using morphology grading only (from concurrent Control Group).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Shehua Shen, MD, ELD
role: Study Director
affiliation: Progyny, Inc.
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility