<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/NCT03785119</url>
  </required_header>
  <id_info>
    <org_study_id>2018-20</org_study_id>
    <nct_id>NCT03785119</nct_id>
  </id_info>
  <brief_title>Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment</brief_title>
  <acronym>AMIFIV</acronym>
  <official_title>Improvement of in Vitro Fertilization Implantation by Soluble CD146 Dose in Embryonic Culture Environment : Multicenter Prospective Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</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 study of implantation potential of the embryo stay a priority in In Vitro Fertilization&#xD;
      (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on&#xD;
      morphologic criteria, approved by literature but not perfect. Implantation's markers&#xD;
      identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy&#xD;
      failure, represent a major issue in IVF, not any biomarker being approved yet.&#xD;
&#xD;
      Among factors regulating embryonic implantation, investigators have recently proposed soluble&#xD;
      CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.&#xD;
&#xD;
      In a monocentric study about 222 transferred embryos at the end of IVF try, investigators&#xD;
      showed that the sCD146 dose in the embryonic culture environment reflected the implantation&#xD;
      ability of embryo, a high rate showing a low implantation potential and this independently of&#xD;
      the embryonic quality. A multicentric prospective study is now required to confirm the&#xD;
      utility of this dosage in clinical practice.&#xD;
&#xD;
      Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of&#xD;
      implantation efficiency, according to choice method of embryo to be transferred :&#xD;
&#xD;
        -  Group A : Standard strategy : Depending on embryonic quality according to criteria&#xD;
           currently selected.&#xD;
&#xD;
        -  Group B : Experimental strategy : Association of embryonic quality according to criteria&#xD;
           currently selected and of sCD146 rate.&#xD;
&#xD;
      Expected Results :&#xD;
&#xD;
        -  Demonstrate a beginning pregnancy test significantly superior in Group B compared to&#xD;
           Group A.&#xD;
&#xD;
        -  Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality&#xD;
           (actual selection criteria) and represent a complementary criteria to choose embryos to&#xD;
           transfer.&#xD;
&#xD;
      Methodology :&#xD;
&#xD;
      - Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The&#xD;
      calculation of the number of staff required includes 151 couples per group.&#xD;
&#xD;
      For this will be include for 24 months, couples benefiting of freezing at least one of the&#xD;
      two embryos and transfer of only one FET.&#xD;
&#xD;
        -  Test the same day of environment freezing where frozen embryos were cultivated. sCD146&#xD;
           dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment&#xD;
           before FET.&#xD;
&#xD;
        -  Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.&#xD;
&#xD;
        -  Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to&#xD;
           each included couple.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 2019</start_date>
  <completion_date type="Anticipated">January 2023</completion_date>
  <primary_completion_date type="Anticipated">January 2023</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>Beginner pregnancy rate at 1st transfer (%)</measure>
    <time_frame>0 to 9 months after FET</time_frame>
    <description>Corresponds to number of defined pregnancy by plasmatic quantity of hCG (human chorionic gonadotropin) &gt;100 UI/l 15 days after FET/number of FET.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Beginner pregnancy rate at 2nd or 3rd transfer</measure>
    <time_frame>0 to 9 months after FET</time_frame>
    <description>Corresponds to number of defined pregnancy by plasmatic quantity of hCG &gt;100 UI/l 15 days after FET/number of FET.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">318</enrollment>
  <condition>in Vitro Fertilization</condition>
  <arm_group>
    <arm_group_label>Standard strategy</arm_group_label>
    <description>According to embryo quality (morphologic criteria)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental strategy</arm_group_label>
    <description>Association of embryo quality and sCD146 rate</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Couples benefiting of at least one of the two embryos and a transfer of one frozen embryo&#xD;
        (FET)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Pre Inclusion Criteria:&#xD;
&#xD;
          -  Women aged [18;42] years&#xD;
&#xD;
          -  Men aged &gt; 18 years&#xD;
&#xD;
          -  Trying an IVF with :&#xD;
&#xD;
          -  Frozen supernumerary embryo after fresh embryo transfer realised at the end of the try&#xD;
             or frozen embryo (frozen all), without immediately transfer possibility (ovulation&#xD;
             hyperstimulation context/ hyperprogesteronemia for example)&#xD;
&#xD;
          -  Freezing at least 2 embryos frozen separately (1/vial)&#xD;
&#xD;
          -  Whatever attempt rank&#xD;
&#xD;
          -  Whatever MAP (Medically Assisted Procreation) technics (IVF/ICSI)&#xD;
&#xD;
          -  Potential transfer of one frozen embryo&#xD;
&#xD;
          -  Volunteer couples to participate at the study, received informations about this&#xD;
             protocol and giving both their non opposition&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
        - FET realization in the selected population&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal to participate at the study of at least one member of the couple&#xD;
&#xD;
          -  Inclusion realized for a previous attempt&#xD;
&#xD;
          -  IVF try with a third-party&#xD;
&#xD;
          -  IVF try without embryo freezing&#xD;
&#xD;
          -  Freezing only one embryo&#xD;
&#xD;
          -  Non separately freezing of embryos (2/vial)&#xD;
&#xD;
          -  Female patients &lt;18 years and &gt;42 years&#xD;
&#xD;
          -  Male patients &lt;18 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>42 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean Olivier Arnaud</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hôpitaux de Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Odile Lacroix-Paulmyer, PUPH</last_name>
    <phone>+33 (0)4 91 38 13 78</phone>
    <email>odile.lacroix-paulmyer@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Service de Biologie de la Reproduction</name>
      <address>
        <city>Marseille</city>
        <zip>13005</zip>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Odile Lacroix-Paulmyer, PUPH</last_name>
      <phone>04 91 38 13 78</phone>
      <email>odile.lacroix-paulmyer@ap-hm.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>December 19, 2018</last_update_submitted>
  <last_update_submitted_qc>December 19, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2018</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/NCT03785119
org study id: 2018-20
nct id: NCT03785119
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study of implantation potential of the embryo stay a priority in In Vitro Fertilization
      (IVF). Indeed, the selection of embryos to transfer is actually based in routine check on
      morphologic criteria, approved by literature but not perfect. Implantation's markers
      identification, allowing to choose the embryo(s) to transfer and then decrease pregnancy
      failure, represent a major issue in IVF, not any biomarker being approved yet.

      Among factors regulating embryonic implantation, investigators have recently proposed soluble
      CD146, coming from proteolytic cleavage of the CD146 membrane, angiogenic bond molecule.

      In a monocentric study about 222 transferred embryos at the end of IVF try, investigators
      showed that the sCD146 dose in the embryonic culture environment reflected the implantation
      ability of embryo, a high rate showing a low implantation potential and this independently of
      the embryonic quality. A multicentric prospective study is now required to confirm the
      utility of this dosage in clinical practice.

      Primary objective : Compared 2 frozen embryo transfer (FET) strategies in terms of
      implantation efficiency, according to choice method of embryo to be transferred :

        -  Group A : Standard strategy : Depending on embryonic quality according to criteria
           currently selected.

        -  Group B : Experimental strategy : Association of embryonic quality according to criteria
           currently selected and of sCD146 rate.

      Expected Results :

        -  Demonstrate a beginning pregnancy test significantly superior in Group B compared to
           Group A.

        -  Confirmed that sCD146 is an independent biomarker of morphologic embryonic quality
           (actual selection criteria) and represent a complementary criteria to choose embryos to
           transfer.

      Methodology :

      - Multicentric prospective study with 2 groups of Frozen Embryo Transfer (FET); The
      calculation of the number of staff required includes 151 couples per group.

      For this will be include for 24 months, couples benefiting of freezing at least one of the
      two embryos and transfer of only one FET.

        -  Test the same day of environment freezing where frozen embryos were cultivated. sCD146
           dosage by ELISA technic (Enzyme Linked ImmunoSorbent Assay) in thus culture environment
           before FET.

        -  Implantation potential analyze of each transfer embryo (FET) according to sCD146 rate.

        -  Following of the FET future(pregnancy, childbirth) : maximum 9 months after attempt to
           each included couple.
observational model: Cohort
time perspective: Prospective
measure: Beginner pregnancy rate at 1st transfer (%)
time frame: 0 to 9 months after FET
description: Corresponds to number of defined pregnancy by plasmatic quantity of hCG (human chorionic gonadotropin) >100 UI/l 15 days after FET/number of FET.
measure: Beginner pregnancy rate at 2nd or 3rd transfer
time frame: 0 to 9 months after FET
description: Corresponds to number of defined pregnancy by plasmatic quantity of hCG >100 UI/l 15 days after FET/number of FET.
arm group label: Standard strategy
description: According to embryo quality (morphologic criteria)
arm group label: Experimental strategy
description: Association of embryo quality and sCD146 rate
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 42 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jean Olivier Arnaud
role: Study Director
affiliation: Assistance Publique Hôpitaux de Marseille
last name: Odile Lacroix-Paulmyer, PUPH
phone: +33 (0)4 91 38 13 78
email: odile.lacroix-paulmyer@ap-hm.fr
facility: 
contact: 
country: France
responsible party type: Sponsor