<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/NCT01715545</url>
  </required_header>
  <id_info>
    <org_study_id>200601YJ</org_study_id>
    <nct_id>NCT01715545</nct_id>
  </id_info>
  <brief_title>Availability of Poor Quality Embryos</brief_title>
  <acronym>Availability</acronym>
  <official_title>Availability of Poor Quality Embryos in Frozen-thawed Embryo Transfer Cycles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The Second Affiliated Hospital of Kunming Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The Second Affiliated Hospital of Kunming Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to explore a method to identify the viability of day-3 poor&#xD;
      quality embryos&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing&#xD;
      numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy&#xD;
      and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are&#xD;
      further cultured to different developmental stage and then cryopreserved. The viability of&#xD;
      these embryos are tested in frozen-thawed transfer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>pregnancy rate</measure>
    <time_frame>5 weeks</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">481</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>day-3 poor quality embryos</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>developmental stage</arm_group_label>
    <description>day3 poor quality embryos day4 morular day-5/6 blastocyst</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        unfertile women&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unfertile women&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  women older than 40 years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jie Yang</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Second Affiliated Hospital of Kunming Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Kunming Medical University</name>
      <address>
        <city>Kunming</city>
        <state>Yunnan</state>
        <zip>650101</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>(1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244</citation>
  </reference>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 29, 2012</study_first_posted>
  <last_update_submitted>October 25, 2012</last_update_submitted>
  <last_update_submitted_qc>October 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 29, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The Second Affiliated Hospital of Kunming Medical University</investigator_affiliation>
    <investigator_full_name>Yang Jie</investigator_full_name>
    <investigator_title>The Second Affiliated Hospital of Kunming Medical University</investigator_title>
  </responsible_party>
  <keyword>day-3 poor quality embryo</keyword>
  <keyword>vitrification</keyword>
  <keyword>clinical outcome</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/NCT01715545
org study id: 200601YJ
nct id: NCT01715545
lead sponsor: 
has dmc: No
The purpose of this study is to explore a method to identify the viability of day-3 poor
      quality embryos
Day-3 poor quality embryos are related to significant lower clinical pregnancy,so freezing
      numerous poor quality embryos are clinical impractical. To ensure the successful pregnancy
      and to enhance the availability of the poor quality embryos, day-3 poor quality embryos are
      further cultured to different developmental stage and then cryopreserved. The viability of
      these embryos are tested in frozen-thawed transfer.
observational model: Cohort
time perspective: Retrospective
measure: pregnancy rate
time frame: 5 weeks
arm group label: day-3 poor quality embryos
arm group label: developmental stage
description: day3 poor quality embryos day4 morular day-5/6 blastocyst
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 20 Years
maximum age: 40 Years
healthy volunteers: No
last name: Jie Yang
role: Principal Investigator
affiliation: The Second Affiliated Hospital of Kunming Medical University
facility: 
country: China
citation: (1) Lu LI, Xiao-xi SUN, Jun-ling CHEN, et al. Analysis of Factors Influencing Pregnancy Rate in Frozen-thawed Embryo Transfer. Journal of Reproduction and Contraception (2004) 15 (4):239-244
responsible party type: Principal Investigator
investigator affiliation: The Second Affiliated Hospital of Kunming Medical University
investigator full name: Yang Jie
investigator title: The Second Affiliated Hospital of Kunming Medical University
mesh term: Infertility