<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/NCT03777358</url>
  </required_header>
  <id_info>
    <org_study_id>MD.18.10.99</org_study_id>
    <nct_id>NCT03777358</nct_id>
  </id_info>
  <brief_title>Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women</brief_title>
  <official_title>A Prospective Study Comparing Three-dimensional Ultrasonography Versus Hysteroscopy in Evaluation of Uterine Cavity in Infertile Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hatem AbuHashim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mansoura 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>
      Hysteroscopy has now become a gold-standard technique carried out for uterine cavity&#xD;
      assessment in infertile women. Apart from direct visualizing of the endometrium by the naked&#xD;
      eye, pathologies missed by other modalities of investigation can be picked up and managed&#xD;
      appropriately. Unfortunately, the procedure itself is not free from complications e.g.&#xD;
      perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and&#xD;
      considered as an invasive procedure.&#xD;
&#xD;
      Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are&#xD;
      non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in&#xD;
      identifying uterine cavity abnormalities due to its ability to obtain a view of three&#xD;
      different planes of the uterus, which could be used to locate the position of intracavitary&#xD;
      pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have&#xD;
      41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a&#xD;
      non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but&#xD;
      its sensitivity, specificity and accuracy still a matter of debate and warrants more&#xD;
      evaluation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">January 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2021</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>Diagnostic accuracy of 3D-TVS</measure>
    <time_frame>At 1 week postmenstrual</time_frame>
    <description>The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Female Infertility</condition>
  <arm_group>
    <arm_group_label>Three-dimensional transvaginal ultrasonography (3D-TVS)</arm_group_label>
    <description>The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>3D-TVS</intervention_name>
    <description>The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed</description>
    <arm_group_label>Three-dimensional transvaginal ultrasonography (3D-TVS)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Infertile women (primary or secondary) aged between 18 and 40 years.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infertile women (primary or secondary)&#xD;
&#xD;
          -  Age between 18 and 40 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age&lt;18 years and˃ 40 years.&#xD;
&#xD;
          -  pelvic inflammatory disease.&#xD;
&#xD;
          -  .Active uterine bleeding&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hatem Abu Hashim, MD. FRCOG. PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Faculty of Medicine, Mansoura University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mohamed Fekry, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Faculty of Medicine, Mansoura University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mansoura University Hospitals</name>
      <address>
        <city>Mansourah</city>
        <state>Dakahlia Governorate</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Ahmadi F, Rashidy Z, Haghighi H, Akhoond M, Niknejadi M, Hemat M, Shamsipour M. Uterine cavity assessment in infertile women: Sensitivity and specificity of three-dimensional Hysterosonography versus Hysteroscopy. Iran J Reprod Med. 2013 Dec;11(12):977-82.</citation>
    <PMID>24639723</PMID>
  </reference>
  <verification_date>July 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>July 13, 2019</last_update_submitted>
  <last_update_submitted_qc>July 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 16, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mansoura University</investigator_affiliation>
    <investigator_full_name>Hatem AbuHashim</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infertility</mesh_term>
    <mesh_term>Infertility, Female</mesh_term>
  </condition_browse>
  <!-- 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/NCT03777358
org study id: MD.18.10.99
nct id: NCT03777358
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Hysteroscopy has now become a gold-standard technique carried out for uterine cavity
      assessment in infertile women. Apart from direct visualizing of the endometrium by the naked
      eye, pathologies missed by other modalities of investigation can be picked up and managed
      appropriately. Unfortunately, the procedure itself is not free from complications e.g.
      perforation, cervical laceration, bleeding, limited access in cases of cervical stenosis and
      considered as an invasive procedure.

      Two-dimensional transvaginal ultrasonography (2D-TVS)and Three-dimensional TVS (3D-TVS) are
      non-invasive methods for evaluating the uterine cavity. The3D-TVS is superior to 2D-TVS in
      identifying uterine cavity abnormalities due to its ability to obtain a view of three
      different planes of the uterus, which could be used to locate the position of intracavitary
      pathology. Reports vary regarding the diagnostic accuracy of 3D-TVS that was reported to have
      41.3-81.5% sensitivity and 94.6-98.7% specificity. So it became clear that 3D-TVS is a
      non-invasive and safe diagnostic tool for evaluation of the uterine cavity abnormalities but
      its sensitivity, specificity and accuracy still a matter of debate and warrants more
      evaluation.
observational model: Cohort
time perspective: Prospective
measure: Diagnostic accuracy of 3D-TVS
time frame: At 1 week postmenstrual
description: The diagnostic accuracy of 3D-TVS in comparison with hysteroscopy for evaluation of uterine cavity abnormalities in infertile women.
arm group label: Three-dimensional transvaginal ultrasonography (3D-TVS)
description: The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then, hysteroscopy will be performed.
intervention type: Device
intervention name: 3D-TVS
description: The 3D-TVS will be done by an experienced gynecological sonographer. The uterine cavity will be assessed by obtaining a mid-coronal view. Then hysteroscopy will be performed
arm group label: Three-dimensional transvaginal ultrasonography (3D-TVS)
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: No
last name: Hatem Abu Hashim, MD. FRCOG. PhD
role: Study Chair
affiliation: Faculty of Medicine, Mansoura University
last name: Mohamed Fekry, MSc
role: Principal Investigator
affiliation: Faculty of Medicine, Mansoura University
facility: 
country: Egypt
citation: Ahmadi F, Rashidy Z, Haghighi H, Akhoond M, Niknejadi M, Hemat M, Shamsipour M. Uterine cavity assessment in infertile women: Sensitivity and specificity of three-dimensional Hysterosonography versus Hysteroscopy. Iran J Reprod Med. 2013 Dec;11(12):977-82.
PMID: 24639723
responsible party type: Sponsor-Investigator
investigator affiliation: Mansoura University
investigator full name: Hatem AbuHashim
investigator title: Professor
mesh term: Infertility
mesh term: Infertility, Female