<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/NCT02988544</url>
  </required_header>
  <id_info>
    <org_study_id>RECHMPL16_0267</org_study_id>
    <nct_id>NCT02988544</nct_id>
  </id_info>
  <brief_title>Artificial Shrinkage of Fresh Blastocysts</brief_title>
  <acronym>BlastoCollapse</acronym>
  <official_title>Artificial Shrinkage of Fresh Blastocyst: Impact on Success Rates in Assisted Reproductive Technology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Montpellier</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Montpellier</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 study is to determine if collapsing an embryo (or making it fold compactly by&#xD;
      taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in&#xD;
      assisted reproductive technology (ART).&#xD;
&#xD;
      Women coming to our ART center will be randomized in two groups : the collapsing group and a&#xD;
      control group.&#xD;
&#xD;
      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be&#xD;
      determined in each group and correlated to pregnancy occurrence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective randomized study designed to determine if artificial shrinkage (AS)&#xD;
      before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo&#xD;
      transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two&#xD;
      arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to&#xD;
      transfer and a control group.&#xD;
&#xD;
      Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy&#xD;
      and cell free DNA concentration in culture medium will be evaluated in the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2018</start_date>
  <completion_date type="Actual">February 22, 2022</completion_date>
  <primary_completion_date type="Actual">August 20, 2021</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>Supportive Care</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical pregnancy rate embryo transfer</measure>
    <time_frame>5 weeks</time_frame>
    <description>Clinical pregnancy rate by transfer evaluate by the visualization of at least one gestational sac with fetal heart activity during pelvic ultrasound confirmed by a positive result of the quantitative βHCG blood test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Twin pregnancy rate by transfer</measure>
    <time_frame>5 weeks</time_frame>
    <description>Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Free DNA level</measure>
    <time_frame>Baseline</time_frame>
    <description>Free DNA content contained in the drop of culture medium collected after transfer.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">150</enrollment>
  <condition>Infertility Assisted Reproductive Technology</condition>
  <arm_group>
    <arm_group_label>Artificial shrinkage (AS) group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention on blastocoelic</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Artificial shrinkage</intervention_name>
    <description>Artificial shrinkage of blastocyst</description>
    <arm_group_label>Artificial shrinkage (AS) group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Couple eligible for a transfer of a single embryo at the blastocyst stage&#xD;
&#xD;
          -  Available couple for a follow up of 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Attempt with frozen embryo or frozen oocyte&#xD;
&#xD;
          -  Attempt with a pre-implantation diagnosis&#xD;
&#xD;
          -  Patient has not signed informed consent&#xD;
&#xD;
          -  Couple in a period of exclusion determined by a previous study&#xD;
&#xD;
          -  Couple under legal protection, guardianship or guardianship&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>43 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anna AG GALA, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Montpellier</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montpellier University Hospital</name>
      <address>
        <city>Montpellier</city>
        <zip>34295</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 6, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>March 4, 2022</last_update_submitted>
  <last_update_submitted_qc>March 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Single blastocyst embryo transfer</keyword>
  <keyword>Artificial Shrinkage</keyword>
  <keyword>Clinical pregnancy rate</keyword>
  <keyword>Cell free</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/NCT02988544
org study id: RECHMPL16_0267
nct id: NCT02988544
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to determine if collapsing an embryo (or making it fold compactly by
      taking away its fluid) before the transfer in the uterine cavity improves pregnancy rates in
      assisted reproductive technology (ART).

      Women coming to our ART center will be randomized in two groups : the collapsing group and a
      control group.

      Pregnancy rates will be compared in the two groups. A biomarker (cell free DNA) will also be
      determined in each group and correlated to pregnancy occurrence.
This is a prospective randomized study designed to determine if artificial shrinkage (AS)
      before transfer of embryos impact clinical pregnancy rate in single blastocyst embryo
      transfer (SBET) cycle. Women elected for SBET will be randomized on transfer day in two
      arms:the AS group where blastocoelic cavity is artificially reduced by a laser pulse prior to
      transfer and a control group.

      Clinical pregnancy rates will be compared. Secondarily, rate of monozygotic twin pregnancy
      and cell free DNA concentration in culture medium will be evaluated in the two groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Participant, Investigator)
measure: Clinical pregnancy rate embryo transfer
time frame: 5 weeks
description: Clinical pregnancy rate by transfer evaluate by the visualization of at least one gestational sac with fetal heart activity during pelvic ultrasound confirmed by a positive result of the quantitative βHCG blood test.
measure: Twin pregnancy rate by transfer
time frame: 5 weeks
description: Twin pregnancy rate by transfer evaluate the presence of 2 cardiac activities on ultrasound.
measure: Free DNA level
time frame: Baseline
description: Free DNA content contained in the drop of culture medium collected after transfer.
arm group label: Artificial shrinkage (AS) group
arm group type: Experimental
description: The Artificial shrinkage group where blastocoelic cavity is artificially reduced by a laser pulse prior to transfer
arm group label: Control group
arm group type: No Intervention
description: No intervention on blastocoelic
intervention type: Procedure
intervention name: Artificial shrinkage
description: Artificial shrinkage of blastocyst
arm group label: Artificial shrinkage (AS) group
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 43 Years
healthy volunteers: No
last name: Anna AG GALA, MD
role: Principal Investigator
affiliation: University Hospital, Montpellier
facility: 
country: France
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: No