<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/NCT04415489</url>
  </required_header>
  <id_info>
    <org_study_id>18-3077</org_study_id>
    <nct_id>NCT04415489</nct_id>
  </id_info>
  <brief_title>SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF</brief_title>
  <official_title>SIS Versus Office Hysteroscopy for Uterine Cavity Evaluation Prior to IVF: a Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine&#xD;
      cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of&#xD;
      intra-uterine pathology, it is not often used as an initial screening tool because of&#xD;
      provider concerns about in-office tolerability, operating room costs, and use of anesthesia.&#xD;
      The investigators aim to compare SIS and office hysteroscopy with respect to patient and&#xD;
      provider satisfaction. Additionally, the investigators aim to assess the capability of&#xD;
      office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and&#xD;
      reduce delays and supernumerary procedures.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine&#xD;
      cavity evaluation. SIS is often performed as a screening tool in the office for uterine&#xD;
      evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If&#xD;
      uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the&#xD;
      operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine&#xD;
      pathology and offers the opportunity for intervention at time of diagnosis, but often is not&#xD;
      used as the initial screening tool because of provider concerns about in-office tolerability,&#xD;
      equipment cost and maintenance. Technology advancements, however, has introduced an&#xD;
      affordable, disposable, small caliber hysteroscopes with an operative channel to make it&#xD;
      possible for this type of assessment to be performed in the office setting with the addition&#xD;
      of a 'see and treat' modality. If used to perform initial uterine cavity evaluation,&#xD;
      hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia.&#xD;
      If superior specificity is demonstrated, it may also lower the false positive rate,&#xD;
      preventing unnecessary delays to a patient's projected treatment plan, and unnecessary&#xD;
      exposure to anesthesia risks. To date, no randomized control trials have compared the&#xD;
      satisfaction of patients and providers to saline infusion sonography versus office&#xD;
      hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately&#xD;
      address intra-uterine pathology.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 6, 2019</start_date>
  <completion_date type="Actual">December 1, 2020</completion_date>
  <primary_completion_date type="Actual">December 1, 2020</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>
    <intervention_model_description>Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Satisfaction</measure>
    <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
    <description>Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain Scores</measure>
    <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
    <description>Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provider Satisfaction</measure>
    <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
    <description>Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Complete</measure>
    <time_frame>During the allotted procedure only</time_frame>
    <description>Length of time to complete procedure in minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Patients Requiring Secondary Procedure</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Infertility Treatment</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Number of days to achieve planned fertility treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive Predictive Value of SIS</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to Manage Pathology With Office Hysteroscopy</measure>
    <time_frame>During the allotted procedure only</time_frame>
    <description>Number of participants with pathology on hysteroscopy successfully managed within same procedure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Infertility</condition>
  <arm_group>
    <arm_group_label>Office Hysteroscopy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Infusion Sonography (SIS)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Office hysteroscopy</intervention_name>
    <description>Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
    <arm_group_label>Office Hysteroscopy</arm_group_label>
    <other_name>LiNA OperaScope</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18 - 50&#xD;
&#xD;
          -  Patients undergoing routine cavity evaluation for planned in vitro-fertilization&#xD;
             cycles&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical or radiologic suspicion of intrauterine pathology including myomas, severe&#xD;
             intrauterine adhesions or retained products of conception&#xD;
&#xD;
          -  Those with medical criteria not suitable office hysteroscopy due to requirement of&#xD;
             advanced tools or preparation not available in the office such as history of bleeding&#xD;
             disorder or medical co-morbidity&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sarah Moustafa, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Linnea Goodman, MD</last_name>
    <role>Study Chair</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UNC Fertility</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27616</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <results_first_submitted>March 17, 2021</results_first_submitted>
  <results_first_submitted_qc>March 17, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">April 14, 2021</results_first_posted>
  <last_update_submitted>April 29, 2021</last_update_submitted>
  <last_update_submitted_qc>April 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Assisted Reproduction</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>Yes</sharing_ipd>
    <ipd_description>Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Beginning 9 months and ending 3 years following article publication.</ipd_time_frame>
    <ipd_access_criteria>Investigator proposing to use data has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 10, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT04415489/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Office Hysteroscopy</title>
          <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
        </group>
        <group group_id="P2">
          <title>Saline Infusion Sonography (SIS)</title>
          <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="50"/>
                <participants group_id="P2" count="50"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Office Hysteroscopy</title>
          <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
        </group>
        <group group_id="B2">
          <title>Saline Infusion Sonography (SIS)</title>
          <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="50"/>
            <count group_id="B2" value="50"/>
            <count group_id="B3" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.9" spread="4.6"/>
                    <measurement group_id="B2" value="34.7" spread="4.9"/>
                    <measurement group_id="B3" value="34.3" spread="4.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race/Ethnicity</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="42"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="81"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Hispanic</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</title>
          <population>BMI data were missing for 5 participants in the SIS arm.</population>
          <units>Kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="45"/>
                    <count group_id="B3" value="95"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.2" spread="6.4"/>
                    <measurement group_id="B2" value="27.7" spread="6.4"/>
                    <measurement group_id="B3" value="26.9" spread="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Infertility Diagnosis</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Diminished ovarian reserve</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Endometriosis</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Ovulatory dysfunction</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="17"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male factor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Tubal factor</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unexplained</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Prior Uterine Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Dilation and curettage</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Myomectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Polypectomy</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Lysis of adhesions</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Caesarean section</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Other</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Uterine Pathology</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>History of uterine pathology</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No history of uterine pathology</title>
                  <measurement_list>
                    <measurement group_id="B1" value="48"/>
                    <measurement group_id="B2" value="46"/>
                    <measurement group_id="B3" value="94"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Vaginal Delivery History</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Prior Vaginal Delivery</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
                <category>
                  <title>No prior Vaginal Delivery</title>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="39"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Prior Cervical Surgery</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="50"/>
                    <count group_id="B2" value="50"/>
                    <count group_id="B3" value="100"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Satisfaction</title>
        <description>Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
        <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Satisfaction</title>
          <description>Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.92" spread="0.34"/>
                    <measurement group_id="O2" value="4.84" spread="4.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.57</p_value>
            <p_value_desc>The a priori threshold for statistical significance was p &lt; 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Pain Scores</title>
        <description>Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).</description>
        <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Scores</title>
          <description>Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.38" spread="1.85"/>
                    <measurement group_id="O2" value="2.44" spread="1.64"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.01</p_value>
            <p_value_desc>The a priori threshold for statistical significance was p &lt; 0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Provider Satisfaction</title>
        <description>Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
        <time_frame>Immediately following imaging modality (less than 30 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Provider Satisfaction</title>
          <description>Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Surveys analyzed</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="5"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Surveys analyzed</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.76" spread="0.69"/>
                    <measurement group_id="O2" value="4.56" spread="0.81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.11</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt; 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Complete</title>
        <description>Length of time to complete procedure in minutes</description>
        <time_frame>During the allotted procedure only</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Complete</title>
          <description>Length of time to complete procedure in minutes</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.61" spread="2.42"/>
                    <measurement group_id="O2" value="3.98" spread="2.03"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.16</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt; 0.05.</p_value_desc>
            <method>t-test, 2 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Patients Requiring Secondary Procedure</title>
        <description>Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Patients Requiring Secondary Procedure</title>
          <description>Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt; 0.01</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt; 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Infertility Treatment</title>
        <description>Number of days to achieve planned fertility treatment</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <population>Number of Patients requiring secondary procedure was used instead to represent potential for treatment delay. This measure was abandoned and no data was collected, based on the following factors making it less reliable: (1) variability of ability to add a second procedure case on the same day (for patient and/or provider), and (2) presence of other uncontrollable factors contributing to fertility treatment delay</population>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Infertility Treatment</title>
          <description>Number of days to achieve planned fertility treatment</description>
          <population>Number of Patients requiring secondary procedure was used instead to represent potential for treatment delay. This measure was abandoned and no data was collected, based on the following factors making it less reliable: (1) variability of ability to add a second procedure case on the same day (for patient and/or provider), and (2) presence of other uncontrollable factors contributing to fertility treatment delay</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Positive Predictive Value of SIS</title>
        <description>Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy</description>
        <time_frame>Through study completion, up to 1 year</time_frame>
        <population>Reported for those participants with abnormal finding during SIS procedure</population>
        <group_list>
          <group group_id="O1">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Positive Predictive Value of SIS</title>
          <description>Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy</description>
          <population>Reported for those participants with abnormal finding during SIS procedure</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="11"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Ability to Manage Pathology With Office Hysteroscopy</title>
        <description>Number of participants with pathology on hysteroscopy successfully managed within same procedure</description>
        <time_frame>During the allotted procedure only</time_frame>
        <population>Participants with abnormal finding during office hysteroscopy</population>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
        </group_list>
        <measure>
          <title>Ability to Manage Pathology With Office Hysteroscopy</title>
          <description>Number of participants with pathology on hysteroscopy successfully managed within same procedure</description>
          <population>Participants with abnormal finding during office hysteroscopy</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="17"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Post-Hoc</type>
        <title>Number of Participants With Pathology Found</title>
        <description>Descriptive characterization of pathology identified for participants, if any, during procedure.</description>
        <time_frame>During the allotted procedure only</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Office Hysteroscopy</title>
            <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
          </group>
          <group group_id="O2">
            <title>Saline Infusion Sonography (SIS)</title>
            <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Pathology Found</title>
          <description>Descriptive characterization of pathology identified for participants, if any, during procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="50"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Polyps</title>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Myoma</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Adhesions</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Retained product</title>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Uterine anomaly</title>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Inconclusive</title>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>None</title>
                  <measurement_list>
                    <measurement group_id="O1" value="31"/>
                    <measurement group_id="O2" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.12</p_value>
            <p_value_desc>The a priori threshold for statistical significance was &lt; 0.05.</p_value_desc>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From the time of office procedure through 30 days afterwards.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Office Hysteroscopy</title>
          <description>Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.&#xD;
Office hysteroscopy: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.</description>
        </group>
        <group group_id="E2">
          <title>Saline Infusion Sonography (SIS)</title>
          <description>This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="50"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Sarah Moustafa, MD</name_or_title>
      <organization>University of North Carolina at Chapel Hill</organization>
      <phone>919-908-0000</phone>
      <email>sarah_moustafa@med.unc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04415489
org study id: 18-3077
nct id: NCT04415489
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine
      cavity evaluation. While hysteroscopy is regarded as the gold standard for diagnosis of
      intra-uterine pathology, it is not often used as an initial screening tool because of
      provider concerns about in-office tolerability, operating room costs, and use of anesthesia.
      The investigators aim to compare SIS and office hysteroscopy with respect to patient and
      provider satisfaction. Additionally, the investigators aim to assess the capability of
      office-based hysteroscopy to manage intra-uterine pathology at the time of diagnosis and
      reduce delays and supernumerary procedures.
Saline infusion sonography (SIS) and hysteroscopy are commonly employed methods for uterine
      cavity evaluation. SIS is often performed as a screening tool in the office for uterine
      evaluation since it is straight-forward to perform, well-tolerated has low overhead cost. If
      uterine pathology is suspected on SIS, subsequent hysteroscopy is typically performed in the
      operating room. Hysteroscopy remains the gold standard for diagnosis of intra-uterine
      pathology and offers the opportunity for intervention at time of diagnosis, but often is not
      used as the initial screening tool because of provider concerns about in-office tolerability,
      equipment cost and maintenance. Technology advancements, however, has introduced an
      affordable, disposable, small caliber hysteroscopes with an operative channel to make it
      possible for this type of assessment to be performed in the office setting with the addition
      of a 'see and treat' modality. If used to perform initial uterine cavity evaluation,
      hysteroscopy may offer expedited diagnosis, treatment, and avoidance of general anesthesia.
      If superior specificity is demonstrated, it may also lower the false positive rate,
      preventing unnecessary delays to a patient's projected treatment plan, and unnecessary
      exposure to anesthesia risks. To date, no randomized control trials have compared the
      satisfaction of patients and providers to saline infusion sonography versus office
      hysteroscopy without anesthesia in initial cavity evaluation with the ability to immediately
      address intra-uterine pathology.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomized controlled trial comparing satisfaction between saline infusion sonography and office hysteroscopy for screening evaluation of the uterine cavity prior to embryo transfer.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Patient Satisfaction
time frame: Immediately following imaging modality (less than 30 minutes)
description: Survey with Likert scale administered to record patients overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
measure: Pain Scores
time frame: Immediately following imaging modality (less than 30 minutes)
description: Survey administered to record patients pain scores during their procedure. Score range is 1-10, with one being minimal pain (better) and 10 being the worst pain ever experienced (worse).
measure: Provider Satisfaction
time frame: Immediately following imaging modality (less than 30 minutes)
description: Survey with Likert scale administered to record providers overall satisfaction during their procedure. Scoring range is 1-5, with 1 corresponding Very Unsatisfied (worse) and 5 corresponding to Very Satisfied (better).
measure: Time to Complete
time frame: During the allotted procedure only
description: Length of time to complete procedure in minutes
measure: Number of Patients Requiring Secondary Procedure
time frame: Through study completion, up to 1 year
description: Number of patients requiring a secondary procedure, either for management of pathology or inability to complete initial procedure.
measure: Time to Infertility Treatment
time frame: Through study completion, up to 1 year
description: Number of days to achieve planned fertility treatment
measure: Positive Predictive Value of SIS
time frame: Through study completion, up to 1 year
description: Number of Participants with SIS Findings, Validated by Subsequent Hysteroscopy
measure: Ability to Manage Pathology With Office Hysteroscopy
time frame: During the allotted procedure only
description: Number of participants with pathology on hysteroscopy successfully managed within same procedure
arm group label: Office Hysteroscopy
arm group type: Active Comparator
description: Use of office hysteroscope with operative port to evaluate uterine cavity, and potentially treat minor abnormalities within the same procedure with hysteroscopic graspers. This involve inserting the hysteroscope through the cervix and instillation of saline for a direct look at the cavity.
arm group label: Saline Infusion Sonography (SIS)
arm group type: No Intervention
description: This is our institution's current first line approach for screening evaluation of the uterine cavity. If not enrolled in the study, patients are required to do this to move forward with embryo transfer. It involves instillation of saline into the uterus via a small catheter with simultaneous imaging with pelvic ultrasound.
intervention type: Device
intervention name: Office hysteroscopy
description: Use of hysteroscopy in the clinical setting to directly visualize the cavity. If pathology amenable to immediate treatment is visualize, removal will be attempted by hysteroscopic graspers.
arm group label: Office Hysteroscopy
other name: LiNA OperaScope
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sarah Moustafa, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
last name: Linnea Goodman, MD
role: Study Chair
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infertility
sharing ipd: Yes
ipd description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: Beginning 9 months and ending 3 years following article publication.
ipd access criteria: Investigator proposing to use data has IRB, IEC, or REB approval and an executed data use/sharing agreement with UNC.
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 