<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/NCT01723267</url>
  </required_header>
  <id_info>
    <org_study_id>rmcavibh-1</org_study_id>
    <nct_id>NCT01723267</nct_id>
  </id_info>
  <brief_title>Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial</brief_title>
  <official_title>Automated 3D (SonoAVC) vs 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rabin Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rabin Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte&#xD;
      maturation and subsequent egg collection is largely based on follicle size. An accurate&#xD;
      assessment of follicle size and appropriate timing of HCG result in retrieval of more mature&#xD;
      oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the&#xD;
      capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,&#xD;
      identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute&#xD;
      dimensions. These measurements include the largest diameters in three orthogonal planes, the&#xD;
      mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter&#xD;
      (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of&#xD;
      this automated technique of follicle measurement vs. standard 2D technology on the timing of&#xD;
      oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D&#xD;
      assessment will increase the rate of mature oocyte collection, and eventually will improve&#xD;
      other treatment outcomes such as fertilization rate.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Not desired&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>percentage of matured oocytes</measure>
    <time_frame>one IVF cycle (within two weeks)</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fertilization rate in ICSI</measure>
    <time_frame>one IVF cycle/ patient (within two weeks)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>3D follicles assessment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During IVF treatment all ultrasound examinations will use 3D- SonoAVC technology. Timing of hCG injection and oocyte collection will be based on follicle volume and 3D-volume based diameter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2D follicles assessment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During IVF treatment all ultrasound examinations will use standard 2D ultrasound. Timing of hCG injection and oocyte collection will be based on follicle diameter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>3D follicles assessment</intervention_name>
    <description>3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)</description>
    <arm_group_label>3D follicles assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>2D follicles assessment</intervention_name>
    <description>2D ultrasound in IVF treatment (vs 3D ultrasound)</description>
    <arm_group_label>2D follicles assessment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age:18-39, cycle number 1-4&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PCOS&#xD;
&#xD;
          -  Endometriosis&#xD;
&#xD;
          -  Poor ovarian response&#xD;
&#xD;
          -  TESA sperm&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>39 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Avi Ben-Haroush, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rabin Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>IVF Unit, Rabin Medical Center</name>
      <address>
        <city>Petach Tikva</city>
        <zip>49100</zip>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>April 10, 2016</last_update_submitted>
  <last_update_submitted_qc>April 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rabin Medical Center</investigator_affiliation>
    <investigator_full_name>avi ben haroush</investigator_full_name>
    <investigator_title>Head of Fertility Preservation Service,IVF and Infertility Unit</investigator_title>
  </responsible_party>
  <keyword>IVF</keyword>
  <keyword>3D ultrasound</keyword>
  <keyword>SonoAVC</keyword>
  <keyword>patients in IVF treatment</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>Undecided</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/NCT01723267
org study id: rmcavibh-1
nct id: NCT01723267
lead sponsor: 
has dmc: No
Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte
      maturation and subsequent egg collection is largely based on follicle size. An accurate
      assessment of follicle size and appropriate timing of HCG result in retrieval of more mature
      oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the
      capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset,
      identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute
      dimensions. These measurements include the largest diameters in three orthogonal planes, the
      mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter
      (d(V)) of the follicle. In the current study the investigators aim to evaluate the use of
      this automated technique of follicle measurement vs. standard 2D technology on the timing of
      oocyte maturation and subsequent oocyte retrieval. The investigators speculate that 3D
      assessment will increase the rate of mature oocyte collection, and eventually will improve
      other treatment outcomes such as fertilization rate.
Not desired
allocation: Randomized
intervention model: Parallel Assignment
masking: None (Open Label)
measure: percentage of matured oocytes
time frame: one IVF cycle (within two weeks)
measure: Fertilization rate in ICSI
time frame: one IVF cycle/ patient (within two weeks)
arm group label: 3D follicles assessment
arm group type: Active Comparator
description: During IVF treatment all ultrasound examinations will use 3D- SonoAVC technology. Timing of hCG injection and oocyte collection will be based on follicle volume and 3D-volume based diameter.
arm group label: 2D follicles assessment
arm group type: Active Comparator
description: During IVF treatment all ultrasound examinations will use standard 2D ultrasound. Timing of hCG injection and oocyte collection will be based on follicle diameter.
intervention type: Other
intervention name: 3D follicles assessment
description: 3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)
arm group label: 3D follicles assessment
intervention type: Other
intervention name: 2D follicles assessment
description: 2D ultrasound in IVF treatment (vs 3D ultrasound)
arm group label: 2D follicles assessment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 39 Years
healthy volunteers: No
last name: Avi Ben-Haroush, MD
role: Principal Investigator
affiliation: Rabin Medical Center
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rabin Medical Center
investigator full name: avi ben haroush
investigator title: Head of Fertility Preservation Service,IVF and Infertility Unit
mesh term: Infertility
sharing ipd: Undecided