<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/NCT03777566</url>
  </required_header>
  <id_info>
    <org_study_id>mohamed amer</org_study_id>
    <nct_id>NCT03777566</nct_id>
  </id_info>
  <brief_title>Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method</brief_title>
  <official_title>Uterine Cavity Volume Measuring With Sonohysterography: A New Objective Method</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Measuring of uterine cavity volume using sonohysterography will be done in two groups of&#xD;
      patients, Group A included 35 patients for home hysterectomy were indicated and group B&#xD;
      includes 150 infertile patients in the childbearing age.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uterine cavity volume will be measured in group A before and after hysterectomy, and in the&#xD;
      group, B will be measured using sonohysterography only using a mathematical method of the sum&#xD;
      of a volume of a cone and part of a sphere.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 10, 2019</start_date>
  <completion_date type="Anticipated">January 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>calculation of uterine cavity volume with an objective method</measure>
    <time_frame>one day</time_frame>
    <description>measuring uterine cavity volume objectively</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">185</enrollment>
  <condition>Cavity</condition>
  <arm_group>
    <arm_group_label>group A</arm_group_label>
    <description>35 patients with an indication for hysterectomy without gross uterine pathology</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group B</arm_group_label>
    <description>150 infertile patients in the childbearing age without gross uterine pathology</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>sonohysterography</intervention_name>
    <description>sonohysterography with measuring the uterine cavity volume</description>
    <arm_group_label>group A</arm_group_label>
    <arm_group_label>group B</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women undergo sonohysterography for gynecologic indication without gross uterine pathology.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients without any gross pathology within the uterus.&#xD;
&#xD;
          2. Patients admitted for hysterectomy.&#xD;
&#xD;
          3. Patients agreed with written consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Virgins.&#xD;
&#xD;
          2. Pregnancy.&#xD;
&#xD;
          3. Systemic blood disease.&#xD;
&#xD;
          4. Any clinical evidence of cervical, uterine or tubal infection.&#xD;
&#xD;
          5. Refusal to undergo saline infusion sonography.&#xD;
&#xD;
          6. Any gross uterine pathology diagnosed clinically or with sonography.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mohamed I Amer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ain Shams University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mohamed I Amer, MD</last_name>
    <phone>00201001519370</phone>
    <email>mohamed_amer810@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>AIn Shams University Maternity Hospital</name>
      <address>
        <city>Cairo</city>
        <zip>11357</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mohamed Amer, MD</last_name>
      <phone>00201001519370</phone>
      <email>mohamed_amer810@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 14, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 17, 2018</study_first_posted>
  <last_update_submitted>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Mohamed I Amer</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <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/NCT03777566
org study id: mohamed amer
nct id: NCT03777566
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Measuring of uterine cavity volume using sonohysterography will be done in two groups of
      patients, Group A included 35 patients for home hysterectomy were indicated and group B
      includes 150 infertile patients in the childbearing age.
Uterine cavity volume will be measured in group A before and after hysterectomy, and in the
      group, B will be measured using sonohysterography only using a mathematical method of the sum
      of a volume of a cone and part of a sphere.
observational model: Cohort
time perspective: Cross-Sectional
measure: calculation of uterine cavity volume with an objective method
time frame: one day
description: measuring uterine cavity volume objectively
arm group label: group A
description: 35 patients with an indication for hysterectomy without gross uterine pathology
arm group label: group B
description: 150 infertile patients in the childbearing age without gross uterine pathology
intervention type: Diagnostic Test
intervention name: sonohysterography
description: sonohysterography with measuring the uterine cavity volume
arm group label: group A
arm group label: group B
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Mohamed I Amer, MD
role: Principal Investigator
affiliation: Ain Shams University
last name: Mohamed I Amer, MD
phone: 00201001519370
email: mohamed_amer810@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Mohamed I Amer
investigator title: Professor
sharing ipd: No