<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/NCT01671644</url>
  </required_header>
  <id_info>
    <org_study_id>2012-AUX-005</org_study_id>
    <secondary_id>TST-1872-p</secondary_id>
    <nct_id>NCT01671644</nct_id>
  </id_info>
  <brief_title>Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study</brief_title>
  <acronym>EPIC</acronym>
  <official_title>Eeva™ Pregnancy Investigational Clinical Study: A Postmarket Follow-Up Study</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 postmarket study is to gather data to evaluate the impact of using Eeva&#xD;
      with traditional morphology grading on clinical pregnancy rates.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva&#xD;
      with traditional morphology grading on clinical pregnancy rates, as compared to a matched&#xD;
      case control group that used morphology grading only to select embryos for transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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 clinical pregnancy</measure>
    <time_frame>5-8 weeks gestational age</time_frame>
    <description>To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Implantation rate (# of implanted embryos out of # of total embryos transferred)</measure>
    <time_frame>5-8 weeks gestational age.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing Pregnancy Rate (gestational week 10-12)</measure>
    <time_frame>Gestational age week 10-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Multiple pregnancy rate</measure>
    <time_frame>Gestational weeks 5-8 and 10-12</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Spontaneous miscarriage rate</measure>
    <time_frame>Gestational age week 10-12</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">104</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Eeva Test Group</arm_group_label>
    <description>Day 3 embryo transfers that used Eeva predictions with morphology grading.</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 a matched 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 ≤ 3.&#xD;
&#xD;
          -  Egg age ≤ 40 years.&#xD;
&#xD;
          -  Planned Day 3 embryo transfer.&#xD;
&#xD;
          -  At least 5 normally fertilized eggs (2PN).&#xD;
&#xD;
          -  All 2PN embryos must be imaged by Eeva.&#xD;
&#xD;
          -  Normal uterine cavity as evaluated by standard methods.&#xD;
&#xD;
          -  Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed&#xD;
             sperm.&#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.&#xD;
&#xD;
          -  Planned &quot;freeze all&quot; cycle (oocytes or embryos).&#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>Gent University Hospital</name>
      <address>
        <city>Gent</city>
        <state>East Flanders</state>
        <zip>9000 Gent</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VU University Medical Center</name>
      <address>
        <city>Amsterdam</city>
        <state>South Holland</state>
        <zip>2500 BH</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>August 21, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 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/NCT01671644
org study id: 2012-AUX-005
secondary id: TST-1872-p
nct id: NCT01671644
lead sponsor: 
has dmc: No
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva
      with traditional morphology grading on clinical pregnancy rates.
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva
      with traditional morphology grading on clinical pregnancy rates, as compared to a matched
      case control group that used morphology grading only to select embryos for transfer.
observational model: Case-Control
measure: Rate of clinical pregnancy
time frame: 5-8 weeks gestational age
description: To compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading only (from a matched concurrent control group at each clinical site comprised of year 2011-2013 patients).
measure: Implantation rate (# of implanted embryos out of # of total embryos transferred)
time frame: 5-8 weeks gestational age.
measure: Ongoing Pregnancy Rate (gestational week 10-12)
time frame: Gestational age week 10-12
measure: Multiple pregnancy rate
time frame: Gestational weeks 5-8 and 10-12
measure: Spontaneous miscarriage rate
time frame: Gestational age week 10-12
arm group label: Eeva Test Group
description: Day 3 embryo transfers that used Eeva predictions with morphology grading.
arm group label: Matched case control group
description: Day 3 embryo transfers using morphology grading only (from a matched 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: 
facility: 
country: Belgium
country: Netherlands
responsible party type: Sponsor
mesh term: Infertility