<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/NCT04484181</url>
  </required_header>
  <id_info>
    <org_study_id>CHUBX 2019/50</org_study_id>
    <nct_id>NCT04484181</nct_id>
  </id_info>
  <brief_title>What Embryoselection for What Chance of Success ? EmbryoSelect Study</brief_title>
  <acronym>EmbryoSelect</acronym>
  <official_title>A Randomized Double-blind Trial Evaluating the Live Birth Rate After Transfer of Embryos Cultured in Time Lapse Incubator Compared With Conventional Incubator: Embryoselect</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Bordeaux</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Programme Hospitalier de Recherche Clinique Inter-Régionale (PHRC-I)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Bordeaux</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the research is to evaluate the results of the first in vitro fertilization (IVF)&#xD;
      attempt according to the type of embryo culture. From the fertilization to the day 2&#xD;
      transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT&#xD;
      offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture&#xD;
      in standard incubator involves discontinuous morphological embryo evaluation. The principal&#xD;
      objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of&#xD;
      women less than 39 years-old.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Embryo evaluation and selection is fundamental in clinical IVF in order to obtain a live&#xD;
      birth in a shorter delay as possible, but minimizing the risk of multiple pregnancies. TLT&#xD;
      was introduced few years ago in clinical practice and allows the continuous follow up of the&#xD;
      embryo development. In IVF centers, embryos are preferentially cultured in TL system with&#xD;
      undisturbed environmental conditions. This provides information about the development of the&#xD;
      embryos in time intervals of 15min and adds kinetic criteria for embryo evaluation and&#xD;
      selection. In conventional incubator, the follow up of embryo development consists in 3&#xD;
      static time point observations. Many reviews and observational studies have discussed the&#xD;
      value of time-lapse monitoring but it is as yet unclear, however, whether the TLT improves&#xD;
      the results of IVF. It has been suggested that the clinical benefits of applying new&#xD;
      technologies should be verified and documented by randomized controlled trials. Moreover, the&#xD;
      cumulative live birth rate and the delay for conception were rarely reported. The study aims&#xD;
      to evaluate the results of the first IVF attempts comparing classical embryo culture in&#xD;
      standard incubator and embryo culture and follow up in TLT. The hypothesis is that the&#xD;
      undisturbed culture and the selection based on continuous time-lapse images improve the&#xD;
      results of the single embryo fresh transfer and increase the cumulative live birth rate.&#xD;
      Patients will be randomized the day of the puncture for the type of culture: standard&#xD;
      incubation or TLT. The results of the fresh and successive vitrified-warmed embryo transfer&#xD;
      will be prospectively collect and patients will be followed until live birth. The attempt&#xD;
      will be considered ended after a live birth, if all the frozen embryos are transferred, after&#xD;
      24 months follow up or after surrender.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Anticipated">September 15, 2027</completion_date>
  <primary_completion_date type="Anticipated">September 15, 2027</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>
    <intervention_model_description>In the two arms, embryos were cultured and selected for fresh transfer. For the standard incubation group, the selection for transfer was based on morphological criteria. In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Live birth rate</measure>
    <time_frame>Month 9</time_frame>
    <description>Live birth rate per punction after the first single embryo fresh transfer. The live birth will be collected 9 months after the first positive pregnancy test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative live birth rate</measure>
    <time_frame>Month 9</time_frame>
    <description>Cumulative live birth rate of the attempt (fresh transfer and vitrified-warmed embryo transfers until live birth or use of all vitrified embryos)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical pregnancy rate</measure>
    <time_frame>Week 6</time_frame>
    <description>Clinical pregnancy rate (cardiac activity at 6 weeks of amenorrhea) per punction and cumulated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ongoing pregnancy rate</measure>
    <time_frame>Week 24</time_frame>
    <description>Ongoing pregnancy rate (at more than 24 weeks of amenorrhea) per punction and cumulated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Delay to obtain a live birth</measure>
    <time_frame>Month 9</time_frame>
    <description>Delay to obtain a live birth (= number of transfers to obtain a live birth)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Embryo culture in time lapse technology (TLT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Embryo culture in conventional incubator</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For the standard incubation group, the selection for transfer was based on morphological criteria. Embryos will be cultured and selected for fresh transfer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Embryo culture in time lapse technology (TLT)</intervention_name>
    <description>In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.</description>
    <arm_group_label>Embryo culture in time lapse technology (TLT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Embryo culture in conventional incubator</intervention_name>
    <description>For the standard incubation group, the selection for transfer will be based on morphological criteria. Embryos will be cultured and selected for fresh transfer.</description>
    <arm_group_label>Embryo culture in conventional incubator</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  first IVF/ICSI attempt with fresh transfer,&#xD;
&#xD;
          -  women ≥18 years-old and &lt;39 years-old,&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  attempts with donor,&#xD;
&#xD;
          -  comprehension problem,&#xD;
&#xD;
          -  frozen gametes,&#xD;
&#xD;
          -  BMI&gt;35 kg/m2,&#xD;
&#xD;
          -  history of 3 or more miscarriages,&#xD;
&#xD;
          -  uterine pathology,&#xD;
&#xD;
          -  serodiscordant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Lucie Chansel-Debordeaux, PharmD</last_name>
    <phone>+335 56 79 56 81</phone>
    <email>lucie.chansel-debordeaux@chu-bordeaux.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>clinique Belharra</name>
      <address>
        <city>Bayonne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Trebesses, PharmD</last_name>
      <phone>+33540078418</phone>
      <email>l.trebesses@axbioocean.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucie Chansel-Debordeaux, PharmD</last_name>
      <phone>+335 56 79 56 81</phone>
      <email>lucie.chansel-debordeaux@chu-bordeaux.fr</email>
    </contact>
    <contact_backup>
      <last_name>Nadege Ansoult</last_name>
      <phone>+335 57 82 07 38</phone>
      <email>nadege.ansoult@chu-bordeaux.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>July 20, 2020</study_first_submitted>
  <study_first_submitted_qc>July 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>April 27, 2023</last_update_submitted>
  <last_update_submitted_qc>April 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Embryo</keyword>
  <keyword>In vitro Fertilization</keyword>
  <keyword>Selection, Time lapse</keyword>
  <keyword>Single embryo transfer</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
  </condition_browse>
  <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/NCT04484181
org study id: CHUBX 2019/50
nct id: NCT04484181
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the research is to evaluate the results of the first in vitro fertilization (IVF)
      attempt according to the type of embryo culture. From the fertilization to the day 2
      transfer, embryos are cultured in standard incubator or in a time lapse technology (TLT). TLT
      offers an uninterrupted culture environment with a morphokinetic evaluation, whereas culture
      in standard incubator involves discontinuous morphological embryo evaluation. The principal
      objective is to compare the live birth rate after the fresh embryo transfer, in a cohort of
      women less than 39 years-old.
Embryo evaluation and selection is fundamental in clinical IVF in order to obtain a live
      birth in a shorter delay as possible, but minimizing the risk of multiple pregnancies. TLT
      was introduced few years ago in clinical practice and allows the continuous follow up of the
      embryo development. In IVF centers, embryos are preferentially cultured in TL system with
      undisturbed environmental conditions. This provides information about the development of the
      embryos in time intervals of 15min and adds kinetic criteria for embryo evaluation and
      selection. In conventional incubator, the follow up of embryo development consists in 3
      static time point observations. Many reviews and observational studies have discussed the
      value of time-lapse monitoring but it is as yet unclear, however, whether the TLT improves
      the results of IVF. It has been suggested that the clinical benefits of applying new
      technologies should be verified and documented by randomized controlled trials. Moreover, the
      cumulative live birth rate and the delay for conception were rarely reported. The study aims
      to evaluate the results of the first IVF attempts comparing classical embryo culture in
      standard incubator and embryo culture and follow up in TLT. The hypothesis is that the
      undisturbed culture and the selection based on continuous time-lapse images improve the
      results of the single embryo fresh transfer and increase the cumulative live birth rate.
      Patients will be randomized the day of the puncture for the type of culture: standard
      incubation or TLT. The results of the fresh and successive vitrified-warmed embryo transfer
      will be prospectively collect and patients will be followed until live birth. The attempt
      will be considered ended after a live birth, if all the frozen embryos are transferred, after
      24 months follow up or after surrender.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: In the two arms, embryos were cultured and selected for fresh transfer. For the standard incubation group, the selection for transfer was based on morphological criteria. In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm).
primary purpose: Other
masking: Triple (Participant, Care Provider, Investigator)
measure: Live birth rate
time frame: Month 9
description: Live birth rate per punction after the first single embryo fresh transfer. The live birth will be collected 9 months after the first positive pregnancy test
measure: Cumulative live birth rate
time frame: Month 9
description: Cumulative live birth rate of the attempt (fresh transfer and vitrified-warmed embryo transfers until live birth or use of all vitrified embryos)
measure: Clinical pregnancy rate
time frame: Week 6
description: Clinical pregnancy rate (cardiac activity at 6 weeks of amenorrhea) per punction and cumulated
measure: Ongoing pregnancy rate
time frame: Week 24
description: Ongoing pregnancy rate (at more than 24 weeks of amenorrhea) per punction and cumulated
measure: Delay to obtain a live birth
time frame: Month 9
description: Delay to obtain a live birth (= number of transfers to obtain a live birth)
arm group label: Embryo culture in time lapse technology (TLT)
arm group type: Experimental
description: In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.
arm group label: Embryo culture in conventional incubator
arm group type: Active Comparator
description: For the standard incubation group, the selection for transfer was based on morphological criteria. Embryos will be cultured and selected for fresh transfer.
intervention type: Other
intervention name: Embryo culture in time lapse technology (TLT)
description: In the TLT group, the selection for transfer was based on morphological and kinetic criteria (with the use of an algorithm). Embryos will be cultured and selected for fresh transfer.
arm group label: Embryo culture in time lapse technology (TLT)
intervention type: Other
intervention name: Embryo culture in conventional incubator
description: For the standard incubation group, the selection for transfer will be based on morphological criteria. Embryos will be cultured and selected for fresh transfer.
arm group label: Embryo culture in conventional incubator
criteria: 
gender: All
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Lucie Chansel-Debordeaux, PharmD
phone: +335 56 79 56 81
email: lucie.chansel-debordeaux@chu-bordeaux.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No