<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/NCT03799081</url>
  </required_header>
  <id_info>
    <org_study_id>HYMC-00056-18</org_study_id>
    <nct_id>NCT03799081</nct_id>
  </id_info>
  <brief_title>Use of Fetoscopy in Missed Abortion</brief_title>
  <official_title>Use of Fetoscopy in Missed Abortion</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillel Yaffe Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillel Yaffe Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</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 purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as&#xD;
      a powerful diagnostic tool to provide better counseling for couples having experienced&#xD;
      pregnancy loss.&#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 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Women who have undergone a missed abortion in the first trimester who want a surgical treatment option</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Macroscopic anatomic malformations in missed abortions</measure>
    <time_frame>Two years</time_frame>
    <description>The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Minimize intrauterine adhesions through observation</measure>
    <time_frame>Two years</time_frame>
    <description>To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Prevention of retained conception products</measure>
    <time_frame>Two years</time_frame>
    <description>Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Abortion, Missed</condition>
  <arm_group>
    <arm_group_label>Fetoscopy in missed abortion</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women who have decided to undergo fetoscopy in missed abortion</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fetoscopy</intervention_name>
    <description>Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope</description>
    <arm_group_label>Fetoscopy in missed abortion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with missed abortion during the first trimester of pregnancy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Women diagnosed with missed abortion after the first trimester of pregnancy&#xD;
&#xD;
          -  Any contraindication for hysteroscopy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sergio Haimovich, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillel Yaffe Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Emiliya Ilizirov, MD</last_name>
    <phone>972-532323246</phone>
    <email>emiliyailizirova@gmal.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hille Yaffe Medical Center</name>
      <address>
        <city>Hadera</city>
        <zip>38100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <contact>
      <last_name>Emiliya Ilizirov, MD</last_name>
      <email>emiliyailizirova@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 5, 2018</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 10, 2019</study_first_posted>
  <last_update_submitted>January 7, 2019</last_update_submitted>
  <last_update_submitted_qc>January 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abortion, Missed</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/NCT03799081
org study id: HYMC-00056-18
nct id: NCT03799081
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate the use of hysteroscopic embryoscopy or fetoscopy as
      a powerful diagnostic tool to provide better counseling for couples having experienced
      pregnancy loss.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Women who have undergone a missed abortion in the first trimester who want a surgical treatment option
primary purpose: Diagnostic
masking: None (Open Label)
measure: Macroscopic anatomic malformations in missed abortions
time frame: Two years
description: The number and type of macroscopic anatomic malformations in missed abortions will be determined through visual observation using a fetoscope
measure: Minimize intrauterine adhesions through observation
time frame: Two years
description: To minimize intrauterine adhesions that might occur after curettage through the ability to visualize the womb and pregnancy site through a hysteroscope before the surgical procedure so that inadvertent intrauterine adhesions are minimized. After one year, if pregnancy is not achieved (due to intrauterine adhesions that cause infertility), a follow-up hysteroscopy will be performed and intrauterine adhesions can be visualized if they have occurred.
measure: Prevention of retained conception products
time frame: Two years
description: Prevention of retained conception products by hysteroscopy after curettage and visualization and observation of the contents of the womb
arm group label: Fetoscopy in missed abortion
arm group type: Other
description: Women who have decided to undergo fetoscopy in missed abortion
intervention type: Procedure
intervention name: Fetoscopy
description: Fetoscopy is a procedure that enables viewing of the fetus through use of a hysteroscope
arm group label: Fetoscopy in missed abortion
criteria: 
gender: Female
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sergio Haimovich, MD, PhD
role: Principal Investigator
affiliation: Hillel Yaffe Medical Center
last name: Emiliya Ilizirov, MD
phone: 972-532323246
email: emiliyailizirova@gmal.com
facility: 
contact: 
country: Israel
responsible party type: Sponsor
mesh term: Abortion, Missed
sharing ipd: No