<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/NCT02974517</url>
  </required_header>
  <id_info>
    <org_study_id>RMCZZU Time-lapse</org_study_id>
    <nct_id>NCT02974517</nct_id>
  </id_info>
  <brief_title>The Application of Time-lapse System in IVF/ICSI</brief_title>
  <official_title>The Application of Time-lapse System in IVF/ICSI: Can it be Beneficial to Final Pregnancy Outcome?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Zhengzhou University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Zhengzhou University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nowadays, the rapid development of human assisted reproductive technology (ART) has provided&#xD;
      many help for couples with fertility issues. Even take baby home rate has been increased&#xD;
      dramatically in the past several decades; both clinicians and embryologists are still&#xD;
      struggling to improve pregnancy rates. Among all the strategies that the embryologists have&#xD;
      tried, much work has been done to find better embryo culture conditions and embryo quality&#xD;
      evaluation system. Currently, most centers in the world, including ours, are still using&#xD;
      conventional incubators and manual embryo scoring system. This traditional method has several&#xD;
      limitations, such as unstable environment during culture, and embryo scores can be different&#xD;
      judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse&#xD;
      embryo culture and analysis system. It is user-friendly, and suited for routinely daily use.&#xD;
      In addition, its KID Score system can help embryologist select high quality embryos quickly,&#xD;
      which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this&#xD;
      prospective cohort study is to evaluate the use of EmbryoScope® in our center.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients included into this study are divided into three groups:&#xD;
&#xD;
        1. Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated&#xD;
           on day 3 by KID Score system.&#xD;
&#xD;
        2. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated&#xD;
           on day 3 by embryologist.&#xD;
&#xD;
        3. Conventional Group: All embryos are cultured in our daily used incubators; embryo scores&#xD;
           are evaluated on day 3 by embryologist.&#xD;
&#xD;
      The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate,&#xD;
      cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>November 2016</start_date>
  <primary_completion_date type="Anticipated">November 2018</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>5 weeks after embryo transfer</time_frame>
    <description>5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2 pronucleus (2PN) fertilization rate</measure>
    <time_frame>48 hours after oocyte retrieved day</time_frame>
    <description>Number of 2PN/Matured oocytes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Blastocyst formation rate</measure>
    <time_frame>6 days after oocyte retrieved day</time_frame>
    <description>Number of Blastocysts/Number of day 3 embryos cultured to blastocyst</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>High quality embryo rate</measure>
    <time_frame>72 hours after oocyte retrieved day</time_frame>
    <description>High quality embryos that deserve to be transferred or cryopreserved/ Clevaged embryos in total</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">300</enrollment>
  <condition>the Application of Time-lapes System in IVF/ICSI</condition>
  <arm_group>
    <arm_group_label>Time-lapse-Auto</arm_group_label>
    <description>All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Time-lapse-Manual</arm_group_label>
    <description>All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional Group</arm_group_label>
    <description>All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>EmbryoScope®</intervention_name>
    <description>The intervention is EmbryoScope® versus conventional incubators.</description>
    <arm_group_label>Time-lapse-Auto</arm_group_label>
    <arm_group_label>Time-lapse-Manual</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All embyros are from women undergoing IVF/ICSI in our center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  First IVF/ICSI cycle;&#xD;
&#xD;
          -  With normal ovarian reserve(FSH &lt; 10 mIU/mL; antral follicle count&gt;5);&#xD;
&#xD;
          -  Age under 38 years old;&#xD;
&#xD;
          -  With normal uterine;&#xD;
&#xD;
          -  Tubal factor infertility&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-implantation genetic diagnosis cycles;&#xD;
&#xD;
          -  Oocyte donation or sperm donation cycles.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>38 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Haixia Jin, M.D.</last_name>
    <phone>86-13523488589</phone>
    <email>jhxgl@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Zhiqin Bu, M.D.</last_name>
    <phone>86-15981978863</phone>
    <email>rmczzu@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Reproductive Medical Center, 1st Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <state>Henan</state>
        <zip>450052</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Haixia Jin, M.D</last_name>
      <phone>86-13523488589</phone>
      <email>jhxgl@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <reference>
    <citation>Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.</citation>
    <PMID>27553622</PMID>
  </reference>
  <reference>
    <citation>Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.</citation>
    <PMID>26630267</PMID>
  </reference>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2016</study_first_posted>
  <last_update_submitted>November 23, 2016</last_update_submitted>
  <last_update_submitted_qc>November 23, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Zhengzhou University</investigator_affiliation>
    <investigator_full_name>Yingpu Sun</investigator_full_name>
    <investigator_title>Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University</investigator_title>
  </responsible_party>
  <keyword>time-lapes</keyword>
  <keyword>IVF/ICSI</keyword>
  <keyword>pregnancy outcome</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT02974517
org study id: RMCZZU Time-lapse
nct id: NCT02974517
lead sponsor: 
has dmc: No
Nowadays, the rapid development of human assisted reproductive technology (ART) has provided
      many help for couples with fertility issues. Even take baby home rate has been increased
      dramatically in the past several decades; both clinicians and embryologists are still
      struggling to improve pregnancy rates. Among all the strategies that the embryologists have
      tried, much work has been done to find better embryo culture conditions and embryo quality
      evaluation system. Currently, most centers in the world, including ours, are still using
      conventional incubators and manual embryo scoring system. This traditional method has several
      limitations, such as unstable environment during culture, and embryo scores can be different
      judged by different embryologists. EmbryoScope® by Vitrolife is a newly developed time-lapse
      embryo culture and analysis system. It is user-friendly, and suited for routinely daily use.
      In addition, its KID Score system can help embryologist select high quality embryos quickly,
      which leads to an overall increase in pregnancy outcome in IVF/ICSI cycles. The aim of this
      prospective cohort study is to evaluate the use of EmbryoScope® in our center.
All patients included into this study are divided into three groups:

        1. Time-lapse-Auto: All embryos are cultured in EmbryoScope®; embryo scores are evaluated
           on day 3 by KID Score system.

        2. Time-lapse-Manual: All embryos are cultured in EmbryoScope®; embryo scores are evaluated
           on day 3 by embryologist.

        3. Conventional Group: All embryos are cultured in our daily used incubators; embryo scores
           are evaluated on day 3 by embryologist.

      The aim is to compare IVF/ICSI outcomes, such as pregnancy outcome, fertilization rate,
      cleavage rate, high quality embryo rate, blastocyst formation rate, among these three groups.
observational model: Cohort
time perspective: Prospective
measure: Clinical pregnancy rate
time frame: 5 weeks after embryo transfer
description: 5 weeks after embryo transfer, gestational sac with fetal heart present inside uterus
measure: 2 pronucleus (2PN) fertilization rate
time frame: 48 hours after oocyte retrieved day
description: Number of 2PN/Matured oocytes
measure: Blastocyst formation rate
time frame: 6 days after oocyte retrieved day
description: Number of Blastocysts/Number of day 3 embryos cultured to blastocyst
measure: High quality embryo rate
time frame: 72 hours after oocyte retrieved day
description: High quality embryos that deserve to be transferred or cryopreserved/ Clevaged embryos in total
arm group label: Time-lapse-Auto
description: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by KID Score system.
arm group label: Time-lapse-Manual
description: All embryos are cultured in EmbryoScope®; embryo scores are evaluated on day 3 by embryologist.
arm group label: Conventional Group
description: All embryos are cultured in our daily used incubators; embryo scores are evaluated on day 3 by embryologist.
intervention type: Device
intervention name: EmbryoScope®
description: The intervention is EmbryoScope® versus conventional incubators.
arm group label: Time-lapse-Auto
arm group label: Time-lapse-Manual
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 22 Years
maximum age: 38 Years
healthy volunteers: No
last name: Haixia Jin, M.D.
phone: 86-13523488589
email: jhxgl@126.com
last name: Zhiqin Bu, M.D.
phone: 86-15981978863
email: rmczzu@126.com
facility: 
status: Recruiting
contact: 
country: China
citation: Wu YG, Lazzaroni-Tealdi E, Wang Q, Zhang L, Barad DH, Kushnir VA, Darmon SK, Albertini DF, Gleicher N. Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScope(TM)) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study. Reprod Biol Endocrinol. 2016 Aug 24;14(1):49. doi: 10.1186/s12958-016-0181-x.
PMID: 27553622
citation: Lazzaroni-Tealdi E, Barad DH, Albertini DF, Yu Y, Kushnir VA, Russell H, Wu YG, Gleicher N. Oocyte Scoring Enhances Embryo-Scoring in Predicting Pregnancy Chances with IVF Where It Counts Most. PLoS One. 2015 Dec 2;10(12):e0143632. doi: 10.1371/journal.pone.0143632. eCollection 2015.
PMID: 26630267
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Zhengzhou University
investigator full name: Yingpu Sun
investigator title: Director of Reproductive Medical Center, 1st Affilated Hospital, Zhengzhou University
sharing ipd: No