<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/NCT01732900</url>
  </required_header>
  <id_info>
    <org_study_id>GEMA-201201</org_study_id>
    <nct_id>NCT01732900</nct_id>
  </id_info>
  <brief_title>Gene Expression in Cumulus Cells to Predict Pregnancy</brief_title>
  <official_title>The Predictive Value of a Gene Expression Signature in Cumulus Cells Indicative of Embryo Implantation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gema Diagnostics</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gema Diagnostics</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine the performance of a genetic assay, GemART, in&#xD;
      cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in&#xD;
      vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as&#xD;
      measured by the implantation rate of embryos transferred.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Recorded at post-transfer week 4-9</time_frame>
    <description>Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">133</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Morphology</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Embryos selected for transfer will be based on morphology alone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GemART assay</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Embryos selected for transfer will be based upon morphology and GemART assay.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Morphology</intervention_name>
    <description>Embryos selected for transfer will be based upon morphology alone.</description>
    <arm_group_label>Morphology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>GemART assay</intervention_name>
    <description>Embryos selected for transfer will be based upon morphology and GemART assay.</description>
    <arm_group_label>GemART assay</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 21-39 years&#xD;
&#xD;
          -  IVF cycle 1 or 2&#xD;
&#xD;
          -  BMI &lt;35&#xD;
&#xD;
          -  Fertilization method: ICSI and/or IVF&#xD;
&#xD;
          -  Day 3 or day 5 embryo transfer&#xD;
&#xD;
          -  Treatment cycle intended for single or double embryo transfer&#xD;
&#xD;
          -  Use own oocytes, not oocyte donor&#xD;
&#xD;
          -  ≥ 3 embryos at final assessment&#xD;
&#xD;
          -  Donor sperm acceptable&#xD;
&#xD;
          -  Willing to comply with protocol and study procedures&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Polycystic Ovarian Syndrome&#xD;
&#xD;
          -  Presence of fibroid(s): &gt;4 cm intramural or submucosal fibroids&#xD;
&#xD;
          -  History of chemotherapy or radiation to the abdomen or pelvis&#xD;
&#xD;
          -  Use of donor oocytes&#xD;
&#xD;
          -  Use of reinseminated oocytes&#xD;
&#xD;
          -  Preimplantation genetic diagnosis or preimplantation genetic screening during current&#xD;
             IVF cycle&#xD;
&#xD;
          -  Concurrent participation in another clinical study&#xD;
&#xD;
          -  (Male): Surgically removed sperm&#xD;
&#xD;
          -  (Male): &lt;5 million sperm count&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Jarrett, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IVF Indiana</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Reproductive Medicine Institute</name>
      <address>
        <city>Oak Brook</city>
        <state>Illinois</state>
        <zip>60523</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>IVF Indiana</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46280</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reproductive Medicine Associates of Michigan</name>
      <address>
        <city>Troy</city>
        <state>Michigan</state>
        <zip>48084</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.</citation>
    <PMID>23200692</PMID>
  </reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>July 11, 2014</last_update_submitted>
  <last_update_submitted_qc>July 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 14, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>In vitro fertilization</keyword>
  <keyword>Assisted reproduction</keyword>
  <keyword>pregnancy outcome</keyword>
  <keyword>cumulus cells</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/NCT01732900
org study id: GEMA-201201
nct id: NCT01732900
lead sponsor: 
has dmc: No
The purpose of this study is to determine the performance of a genetic assay, GemART, in
      cumulus cells predictive of embryo viability, and pregnancy success in women undergoing in
      vitro fertilization (IVF). Performance is defined as success rate per embryo transferred, as
      measured by the implantation rate of embryos transferred.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Clinical pregnancy rate
time frame: Recorded at post-transfer week 4-9
description: Clinical pregnancy, recorded as either positive or negative, will be determined using vaginal ultrasound during post-transfer week 4-9. Clinical Pregnancy rate for embryos selected using the GemART assay in conjunction with morphology will be compared with clinical pregnancy rate for embryos selected using morphology alone.
arm group label: Morphology
arm group type: Active Comparator
description: Embryos selected for transfer will be based on morphology alone.
arm group label: GemART assay
arm group type: Experimental
description: Embryos selected for transfer will be based upon morphology and GemART assay.
intervention type: Other
intervention name: Morphology
description: Embryos selected for transfer will be based upon morphology alone.
arm group label: Morphology
intervention type: Other
intervention name: GemART assay
description: Embryos selected for transfer will be based upon morphology and GemART assay.
arm group label: GemART assay
criteria: 
gender: Female
minimum age: 21 Years
maximum age: 39 Years
healthy volunteers: No
last name: John Jarrett, MD
role: Principal Investigator
affiliation: IVF Indiana
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Iager AE, Kocabas AM, Otu HH, Ruppel P, Langerveld A, Schnarr P, Suarez M, Jarrett JC, Conaghan J, Rosa GJ, Fernandez E, Rawlins RG, Cibelli JB, Crosby JA. Identification of a novel gene set in human cumulus cells predictive of an oocyte's pregnancy potential. Fertil Steril. 2013 Mar 1;99(3):745-752.e6. doi: 10.1016/j.fertnstert.2012.10.041. Epub 2012 Nov 29.
PMID: 23200692
responsible party type: Sponsor
mesh term: Infertility