<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/NCT02990949</url>
  </required_header>
  <id_info>
    <org_study_id>20160397</org_study_id>
    <nct_id>NCT02990949</nct_id>
  </id_info>
  <brief_title>The Impact of the Timing of Trigger on IVF Success</brief_title>
  <official_title>The Impact of the Timing of Trigger on IVF Success: Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Colorado Center for Reproductive Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fertility Laboratories Of Colorado</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Colorado Center for Reproductive Medicine</source>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the length of ovarian stimulation with the timing of&#xD;
      trigger in an IVF cycle and its potential to impact patient outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Stopped due to lack of enrollement&#xD;
  </why_stopped>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">June 15, 2022</completion_date>
  <primary_completion_date type="Actual">May 9, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested</measure>
    <time_frame>4 weeks after egg retrieval</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Egg maturation: the proportion of mature eggs of total number of eggs retrieved</measure>
    <time_frame>1 week after egg retrieval</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle</measure>
    <time_frame>9 months after frozen embryo transfer</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Fertilization in Vitro</condition>
  <condition>Infertility</condition>
  <condition>Embryonic Development</condition>
  <arm_group>
    <arm_group_label>Testing group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Timing of trigger</intervention_name>
    <arm_group_label>Testing group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Planning to move forward with an IVF cycle&#xD;
&#xD;
          -  Have met the requirements of being a patient at CCRM Colorado&#xD;
&#xD;
          -  AMA: 39-44 years old And/or&#xD;
&#xD;
          -  DOR: AMH &lt; 1 &amp; FSH &gt;10 (age independent)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication for pregnancy&#xD;
&#xD;
          -  Have not fulfilled requirements for IVF cycle&#xD;
&#xD;
          -  Single gene couple or chromosomal rearrangement&#xD;
&#xD;
          -  Severe male factor or testicular surgical sperm removal (need sufficient sperm for&#xD;
             ICSI)&#xD;
&#xD;
          -  One ovary&#xD;
&#xD;
          -  Uterine anomalies&#xD;
&#xD;
          -  Stage III or IV endometriosis&#xD;
&#xD;
          -  Explained recurrent miscarriage&#xD;
&#xD;
          -  PCO or PCOS&#xD;
&#xD;
          -  Using donor oocyte or gestational carrier&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>26 Years</minimum_age>
    <maximum_age>44 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mandy Katz-Jaffe, PhD</last_name>
    <role>Study Director</role>
    <affiliation>CCRM, FLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Colorado Center for Reproductive Medicine</name>
      <address>
        <city>Lone Tree</city>
        <state>Colorado</state>
        <zip>80124</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>October 12, 2022</last_update_submitted>
  <last_update_submitted_qc>October 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT02990949
org study id: 20160397
nct id: NCT02990949
lead sponsor: 
collaborator: 
The aim of this study is to examine the length of ovarian stimulation with the timing of
      trigger in an IVF cycle and its potential to impact patient outcomes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Euploid Embryos: the percentage of euploid embryos produced as analyzed by comprehensive chromosomal screening, of total embryos tested
time frame: 4 weeks after egg retrieval
measure: Egg maturation: the proportion of mature eggs of total number of eggs retrieved
time frame: 1 week after egg retrieval
measure: Live birth outcomes: the incidence of pregnancy resulting in live birth following embryo transfer of embryos produced by this IVF cycle
time frame: 9 months after frozen embryo transfer
arm group label: Testing group
arm group type: Experimental
description: Timing of trigger at end of ovarian stimulation in an IVF cycle: trigger when 2 follicles reach 18mm, OR 1 follicle reaches 18mm AND 1 follicle is between 16-18mm.
arm group label: Control group
arm group type: No Intervention
intervention type: Other
intervention name: Timing of trigger
arm group label: Testing group
criteria: 
gender: Female
minimum age: 26 Years
maximum age: 44 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mandy Katz-Jaffe, PhD
role: Study Director
affiliation: CCRM, FLC
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility