<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/NCT03806153</url>
  </required_header>
  <id_info>
    <org_study_id>2017/385/HP</org_study_id>
    <nct_id>NCT03806153</nct_id>
  </id_info>
  <brief_title>Interest of Morphokinetic Parameters of Early Embryonic Development in the Birth Rates in Vitro Fertilization</brief_title>
  <acronym>EMCIMO</acronym>
  <official_title>Do the Morphokinetic Parameters of Early Embryonic Development Have an Interest in the Choice of the Embryo to be Transferred and Improve Birth Rates in Vitro Fertilization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      In France, nearly 3% of children are conceived by the technique of Assisted Reproductive&#xD;
      Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical&#xD;
      pregnancy by oocyte retrieval or embryo transfer have not changed much. The use of&#xD;
      mono-embryo transfer reduces the risk of multiple pregnancies and associated obstetric&#xD;
      complications. The choice of embryo to transfer or freeze is a key element in improving the&#xD;
      chances of success of IVF. It is usually based on conventional morphological criteria&#xD;
      (reference method) that are punctual, qualitative and subjective. However, embryo morphology&#xD;
      at early stages has little predictive value for obtaining a late-stage embryo and its chances&#xD;
      of implantation. The recent use of time-lapse technology during embryonic culture makes it&#xD;
      possible to associate morphological criteria with continuous monitoring of the kinetics of&#xD;
      embryonic development. The choice of the embryo to be transferred is then made according to&#xD;
      morphokinetic criteria (conventional morphological criteria to which are added the data of&#xD;
      the kinetics of embryonic development).&#xD;
&#xD;
      Two recent retrospective studies give contradictory results, the first shows higher birth&#xD;
      rates in the group of embryos selected according to conventional morphological criteria, the&#xD;
      second concludes that morphokinetic analysis is superior. Morphokinetic criteria would also&#xD;
      be more objective and reproducible. However, the use of morphokinetic parameters remains&#xD;
      controversial in the literature.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">March 1, 2019</start_date>
  <completion_date type="Anticipated">March 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2026</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).</measure>
    <time_frame>36 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">520</enrollment>
  <condition>Reproductive Disorder</condition>
  <arm_group>
    <arm_group_label>Conventional morphology arm (reference method)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Morphokinetic arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Morphokinetic</intervention_name>
    <description>The embryos will be observed at a fixed time and according to morphological criteria (Alpha Specialist Group in Reproductive Medicine and ESHRE, 2011). and all the films obtained will be analyzed. Embryos will be classified according to morphokinetic criteria (Ciray et al., 2014).</description>
    <arm_group_label>Conventional morphology arm (reference method)</arm_group_label>
    <arm_group_label>Morphokinetic arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. For the couple:&#xD;
&#xD;
               -  Couple whose two members are 18 years old and over,&#xD;
&#xD;
               -  Couple whose two members are affiliated to a social security scheme,&#xD;
&#xD;
               -  Couple whose two members read and understood the newsletter and signed the&#xD;
                  consent form for their participation in this research.&#xD;
&#xD;
          2. For the conditions of realization of the ICSI attempt:&#xD;
&#xD;
               -  Couple supported for a 1st or 2nd attempt at in vitro fertilization with sperm&#xD;
                  microinjection (ICSI) for male infertility,&#xD;
&#xD;
               -  In vitro fertilization attempt performed with micro-injection of fresh ejaculated&#xD;
                  spermatozoa.&#xD;
&#xD;
          3. For the man:&#xD;
&#xD;
               -  Couple whose man has an alteration of at least one of the sperm parameters&#xD;
                  according to the WHO (WHO, 2010) for the number, concentration, vitality,&#xD;
                  mobility or morphology according to the modified David classification (Auger and&#xD;
                  Eustache, 2000).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. For the couple:&#xD;
&#xD;
               -  Couple whose wife is under 18 and over 42 and / or the male is under 18 and over&#xD;
                  59&#xD;
&#xD;
               -  Couple already included in the protocol &quot;EMCIMO&quot; for a previous attempt,&#xD;
&#xD;
               -  Couple of which one or both members is deprived by an administrative or judicial&#xD;
                  decision or subject to a legal measure of protection of the majors (safeguard of&#xD;
                  justice or tutelage or curatorship),&#xD;
&#xD;
               -  Couple where one or both members do not speak or understand French.&#xD;
&#xD;
          2. For the conditions of realization of the ICSI attempt:&#xD;
&#xD;
             - In vitro fertilization attempt with the micro-injection of testicular spermatozoa,&#xD;
             epididymal, previously frozen or resulting from a retrograde ejaculation.&#xD;
&#xD;
          3. For the man:&#xD;
&#xD;
               -  Severe oligozoospermia (&lt;100,000 spermatozoa / ejaculate).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 16, 2019</study_first_posted>
  <last_update_submitted>January 15, 2019</last_update_submitted>
  <last_update_submitted_qc>January 15, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03806153
org study id: 2017/385/HP
nct id: NCT03806153
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In France, nearly 3% of children are conceived by the technique of Assisted Reproductive
      Medicine, of which nearly 70% by in vitro fertilization (IVF). The rates of clinical
      pregnancy by oocyte retrieval or embryo transfer have not changed much. The use of
      mono-embryo transfer reduces the risk of multiple pregnancies and associated obstetric
      complications. The choice of embryo to transfer or freeze is a key element in improving the
      chances of success of IVF. It is usually based on conventional morphological criteria
      (reference method) that are punctual, qualitative and subjective. However, embryo morphology
      at early stages has little predictive value for obtaining a late-stage embryo and its chances
      of implantation. The recent use of time-lapse technology during embryonic culture makes it
      possible to associate morphological criteria with continuous monitoring of the kinetics of
      embryonic development. The choice of the embryo to be transferred is then made according to
      morphokinetic criteria (conventional morphological criteria to which are added the data of
      the kinetics of embryonic development).

      Two recent retrospective studies give contradictory results, the first shows higher birth
      rates in the group of embryos selected according to conventional morphological criteria, the
      second concludes that morphokinetic analysis is superior. Morphokinetic criteria would also
      be more objective and reproducible. However, the use of morphokinetic parameters remains
      controversial in the literature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Participant)
measure: The primary endpoint of this study will be the live birth rate by fresh embryo transfer(s).
time frame: 36 months
arm group label: Conventional morphology arm (reference method)
arm group type: Active Comparator
arm group label: Morphokinetic arm
arm group type: Experimental
intervention type: Other
intervention name: Morphokinetic
description: The embryos will be observed at a fixed time and according to morphological criteria (Alpha Specialist Group in Reproductive Medicine and ESHRE, 2011). and all the films obtained will be analyzed. Embryos will be classified according to morphokinetic criteria (Ciray et al., 2014).
arm group label: Conventional morphology arm (reference method)
arm group label: Morphokinetic arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: No
responsible party type: Sponsor