<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/NCT03234569</url>
  </required_header>
  <id_info>
    <org_study_id>16-0967</org_study_id>
    <nct_id>NCT03234569</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility</brief_title>
  <official_title>Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Northwell Health</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Northwell Health</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This pilot study is a collaborative effort between Northwell Health's Departments of&#xD;
      Fertility and Radiology.The aim of this study is to evaluate the feasibility of the&#xD;
      Sonohysterosalpingography (sonoHSG) for it to be determined as the standard of care.&#xD;
      Additionally, it aims to improve the work up of infertility by integrating the examination of&#xD;
      structural abnormalities of the Fallopian tubes and uterus into a single radiation free&#xD;
      ultrasound guided procedure, the sonoHSG.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This pilot study is a collaborative effort between Northwell Health Fertility and the&#xD;
      Radiology Department to streamline the fertility evaluation process and reduce the burden of&#xD;
      stress many fertility patients experience by eliminating an imaging examination which is&#xD;
      painful and exposes the patient to potentially harmful radiation.&#xD;
&#xD;
      The aim of this study is to improve the workup of infertility by integrating the examination&#xD;
      of structural abnormalities of the fallopian tubes and uterus into a single radiation-free&#xD;
      ultrasound guided procedure, the sonohysterosalpingogram (sonoHSG). Confirmation of tubal&#xD;
      patency is extremely important as approximately 25-35% of female infertility can be&#xD;
      attributed to fallopian tube pathology. The current paradigm is to use two separate imaging&#xD;
      exams; the hysterosalpingogram (HSG), a transvaginal procedure that uses radiation and&#xD;
      iodinated contrast to visualize the fallopian tubes, and the sonohysterogram, a transvaginal&#xD;
      procedure that uses ultrasound and saline to visualize the uterus. By using agitated saline,&#xD;
      to produce air bubbles, fallopian tube visualization is optimized during the time of&#xD;
      sonohysterogram (sonoHSG). The investigators plan to also utilize a continuous saline-air&#xD;
      device that may produce a technically superior sonoHSG.&#xD;
&#xD;
      As a result of this study, the Radiology Department and Northwell Health Fertility will work&#xD;
      together to encourage, educate, and support physicians to promote the utility of sonoHSG as&#xD;
      the first imaging examination for the infertility workup. Currently, this institution is not&#xD;
      routinely utilizing the sonoHSG despite the advantages in safety, comfort, and convenience to&#xD;
      the patient. The investigators aim to effect a change in the current practice at this&#xD;
      institution by increasing the knowledge and visibility of the sonoHSG by creating educational&#xD;
      materials for referring physicians, and creating a pilot program that demonstrates the value&#xD;
      and efficacy of the exam. SonoHSG can be performed concurrently at the time of the&#xD;
      sonohysterogram at no additional cost to the patient.&#xD;
&#xD;
      The investigators will enroll 30 patients from Northwell Health Fertility over the course of&#xD;
      one year. Measures of success will include concordance between sonoHSG and HSG in patients&#xD;
      who receive both procedures, and patient surveys evaluating pain utilizing the pain scale. If&#xD;
      sonoHSG proves to be efficacious, future steps will be to educate referring physicians and&#xD;
      patients about the utility of the examination using print materials and a grand rounds&#xD;
      lecture. The investigators will also measure the number of sonoHSGs ordered compared to HSGs&#xD;
      for the evaluation of fallopian tube patency in order to evaluate if there has been a shift&#xD;
      in the standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 31, 2018</start_date>
  <completion_date type="Actual">March 5, 2020</completion_date>
  <primary_completion_date type="Actual">March 5, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Concordance between sonoHSG and HSG results. The sonoHSG and HSG will be considered interchangeable if the level of agreement between them is &gt;= 80%.</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of level of patient pain in regard to sonoHSG versus HSG</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Infertility, Female</condition>
  <arm_group>
    <arm_group_label>sonoHSG</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This is the research procedure and it will be added onto the standard of care procedure for all subjects.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>sonoHSG</intervention_name>
    <description>This procedure uses agitated saline to produce air bubbles at the time of the Sonohysterogram which optimizes fallopian tube visualization. The sonoHSG is free of radiation and use of contrast. In this study, in order to produce the air bubbles at the time of the sonohysterogram, the investigators will be using a continuous saline-air device that may produce a technically superior image. For the ultrasound images, General Electric will be supporting us by providing us the Voluson E10 and RIC5-9-D.</description>
    <arm_group_label>sonoHSG</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Undergoing evaluation for infertility in the Northwell Health System&#xD;
&#xD;
          -  Non-pregnant women age 18-50 years old&#xD;
&#xD;
          -  Subject is not menstruating at the time of study&#xD;
&#xD;
          -  Provide written informed consent and written HIPAA authorization prior to study&#xD;
             initiation&#xD;
&#xD;
          -  Willing to comply with the specified follow-up evaluation schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of active pelvic infection&#xD;
&#xD;
          -  History of tubal ligation or salpingectomy&#xD;
&#xD;
          -  History of adverse reaction to iodinated contrast&#xD;
&#xD;
          -  Subject is pregnant&#xD;
&#xD;
          -  Subject is menstruating at time of study&#xD;
&#xD;
          -  Subject is unable to participate in study evaluations pre- and post-treatment&#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>John Pellerito, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Northwell Health</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Northwell Health- North Shore University Hospital</name>
      <address>
        <city>Manhasset</city>
        <state>New York</state>
        <zip>11030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://link.springer.com/content/pdf/10.1007/s10396-012-0417-0.pdf</url>
    <description>Sonohysterosalpingography: A suitable choice in infertility work up</description>
  </link>
  <reference>
    <citation>Maheux-Lacroix S, Boutin A, Moore L, Bergeron ME, Bujold E, Laberge PY, Lemyre M, Dodin S. Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review protocol. Syst Rev. 2013 Jul 4;2:50. doi: 10.1186/2046-4053-2-50.</citation>
    <PMID>23826862</PMID>
  </reference>
  <reference>
    <citation>Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D. Hysterosalpingo-contrast sonography compared with hysterosalpingography and laparoscopic dye pertubation to evaluate tubal patency. J Am Assoc Gynecol Laparosc. 2003 Aug;10(3):367-72. doi: 10.1016/s1074-3804(05)60264-2.</citation>
    <PMID>14567814</PMID>
  </reference>
  <reference>
    <citation>Marci R, Marcucci I, Marcucci AA, Pacini N, Salacone P, Sebastianelli A, Caponecchia L, Lo Monte G, Rago R. Hysterosalpingocontrast sonography (HyCoSy): evaluation of the pain perception, side effects and complications. BMC Med Imaging. 2013 Aug 23;13:28. doi: 10.1186/1471-2342-13-28.</citation>
    <PMID>23968513</PMID>
  </reference>
  <reference>
    <citation>Luciano DE, Exacoustos C, Luciano AA. Contrast ultrasonography for tubal patency. J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):994-8. doi: 10.1016/j.jmig.2014.05.017. Epub 2014 Jun 6.</citation>
    <PMID>24910933</PMID>
  </reference>
  <reference>
    <citation>Schankath AC, Fasching N, Urech-Ruh C, Hohl MK, Kubik-Huch RA. Hysterosalpingography in the workup of female infertility: indications, technique and diagnostic findings. Insights Imaging. 2012 Oct;3(5):475-83. doi: 10.1007/s13244-012-0183-y. Epub 2012 Jul 17.</citation>
    <PMID>22802083</PMID>
  </reference>
  <reference>
    <citation>Szymusik I, Grzechocinska B, Marianowski P, Kaczynski B, Wielgos M. Factors influencing the severity of pain during hysterosalpingography. Int J Gynaecol Obstet. 2015 May;129(2):118-22. doi: 10.1016/j.ijgo.2014.11.015. Epub 2015 Jan 27.</citation>
    <PMID>25650318</PMID>
  </reference>
  <reference>
    <citation>Handelzalts JE, Levy S, Peled Y, Binyamin L, Wiznitzer A, Goldzweig G, Krissi H. Information seeking and perceptions of anxiety and pain among women undergoing hysterosalpingography. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:41-4. doi: 10.1016/j.ejogrb.2016.04.037. Epub 2016 Apr 30.</citation>
    <PMID>27160813</PMID>
  </reference>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>July 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2017</study_first_posted>
  <last_update_submitted>April 6, 2022</last_update_submitted>
  <last_update_submitted_qc>April 6, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Northwell Health</investigator_affiliation>
    <investigator_full_name>John Pellerito</investigator_full_name>
    <investigator_title>Vice Chair, Education Department of Radiology</investigator_title>
  </responsible_party>
  <keyword>sonohysterosalpingography</keyword>
  <keyword>hysterosalpingography</keyword>
  <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>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03234569/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 26, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/69/NCT03234569/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03234569
org study id: 16-0967
nct id: NCT03234569
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This pilot study is a collaborative effort between Northwell Health's Departments of
      Fertility and Radiology.The aim of this study is to evaluate the feasibility of the
      Sonohysterosalpingography (sonoHSG) for it to be determined as the standard of care.
      Additionally, it aims to improve the work up of infertility by integrating the examination of
      structural abnormalities of the Fallopian tubes and uterus into a single radiation free
      ultrasound guided procedure, the sonoHSG.
This pilot study is a collaborative effort between Northwell Health Fertility and the
      Radiology Department to streamline the fertility evaluation process and reduce the burden of
      stress many fertility patients experience by eliminating an imaging examination which is
      painful and exposes the patient to potentially harmful radiation.

      The aim of this study is to improve the workup of infertility by integrating the examination
      of structural abnormalities of the fallopian tubes and uterus into a single radiation-free
      ultrasound guided procedure, the sonohysterosalpingogram (sonoHSG). Confirmation of tubal
      patency is extremely important as approximately 25-35% of female infertility can be
      attributed to fallopian tube pathology. The current paradigm is to use two separate imaging
      exams; the hysterosalpingogram (HSG), a transvaginal procedure that uses radiation and
      iodinated contrast to visualize the fallopian tubes, and the sonohysterogram, a transvaginal
      procedure that uses ultrasound and saline to visualize the uterus. By using agitated saline,
      to produce air bubbles, fallopian tube visualization is optimized during the time of
      sonohysterogram (sonoHSG). The investigators plan to also utilize a continuous saline-air
      device that may produce a technically superior sonoHSG.

      As a result of this study, the Radiology Department and Northwell Health Fertility will work
      together to encourage, educate, and support physicians to promote the utility of sonoHSG as
      the first imaging examination for the infertility workup. Currently, this institution is not
      routinely utilizing the sonoHSG despite the advantages in safety, comfort, and convenience to
      the patient. The investigators aim to effect a change in the current practice at this
      institution by increasing the knowledge and visibility of the sonoHSG by creating educational
      materials for referring physicians, and creating a pilot program that demonstrates the value
      and efficacy of the exam. SonoHSG can be performed concurrently at the time of the
      sonohysterogram at no additional cost to the patient.

      The investigators will enroll 30 patients from Northwell Health Fertility over the course of
      one year. Measures of success will include concordance between sonoHSG and HSG in patients
      who receive both procedures, and patient surveys evaluating pain utilizing the pain scale. If
      sonoHSG proves to be efficacious, future steps will be to educate referring physicians and
      patients about the utility of the examination using print materials and a grand rounds
      lecture. The investigators will also measure the number of sonoHSGs ordered compared to HSGs
      for the evaluation of fallopian tube patency in order to evaluate if there has been a shift
      in the standard of care.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Concordance between sonoHSG and HSG results. The sonoHSG and HSG will be considered interchangeable if the level of agreement between them is >= 80%.
time frame: 1 year
measure: Quantification of level of patient pain in regard to sonoHSG versus HSG
time frame: 1 year
arm group label: sonoHSG
arm group type: Experimental
description: This is the research procedure and it will be added onto the standard of care procedure for all subjects.
intervention type: Procedure
intervention name: sonoHSG
description: This procedure uses agitated saline to produce air bubbles at the time of the Sonohysterogram which optimizes fallopian tube visualization. The sonoHSG is free of radiation and use of contrast. In this study, in order to produce the air bubbles at the time of the sonohysterogram, the investigators will be using a continuous saline-air device that may produce a technically superior image. For the ultrasound images, General Electric will be supporting us by providing us the Voluson E10 and RIC5-9-D.
arm group label: sonoHSG
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: John Pellerito, MD
role: Principal Investigator
affiliation: Northwell Health
facility: 
country: United States
url: https://link.springer.com/content/pdf/10.1007/s10396-012-0417-0.pdf
description: Sonohysterosalpingography: A suitable choice in infertility work up
citation: Maheux-Lacroix S, Boutin A, Moore L, Bergeron ME, Bujold E, Laberge PY, Lemyre M, Dodin S. Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review protocol. Syst Rev. 2013 Jul 4;2:50. doi: 10.1186/2046-4053-2-50.
PMID: 23826862
citation: Exacoustos C, Zupi E, Carusotti C, Lanzi G, Marconi D, Arduini D. Hysterosalpingo-contrast sonography compared with hysterosalpingography and laparoscopic dye pertubation to evaluate tubal patency. J Am Assoc Gynecol Laparosc. 2003 Aug;10(3):367-72. doi: 10.1016/s1074-3804(05)60264-2.
PMID: 14567814
citation: Marci R, Marcucci I, Marcucci AA, Pacini N, Salacone P, Sebastianelli A, Caponecchia L, Lo Monte G, Rago R. Hysterosalpingocontrast sonography (HyCoSy): evaluation of the pain perception, side effects and complications. BMC Med Imaging. 2013 Aug 23;13:28. doi: 10.1186/1471-2342-13-28.
PMID: 23968513
citation: Luciano DE, Exacoustos C, Luciano AA. Contrast ultrasonography for tubal patency. J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):994-8. doi: 10.1016/j.jmig.2014.05.017. Epub 2014 Jun 6.
PMID: 24910933
citation: Schankath AC, Fasching N, Urech-Ruh C, Hohl MK, Kubik-Huch RA. Hysterosalpingography in the workup of female infertility: indications, technique and diagnostic findings. Insights Imaging. 2012 Oct;3(5):475-83. doi: 10.1007/s13244-012-0183-y. Epub 2012 Jul 17.
PMID: 22802083
citation: Szymusik I, Grzechocinska B, Marianowski P, Kaczynski B, Wielgos M. Factors influencing the severity of pain during hysterosalpingography. Int J Gynaecol Obstet. 2015 May;129(2):118-22. doi: 10.1016/j.ijgo.2014.11.015. Epub 2015 Jan 27.
PMID: 25650318
citation: Handelzalts JE, Levy S, Peled Y, Binyamin L, Wiznitzer A, Goldzweig G, Krissi H. Information seeking and perceptions of anxiety and pain among women undergoing hysterosalpingography. Eur J Obstet Gynecol Reprod Biol. 2016 Jul;202:41-4. doi: 10.1016/j.ejogrb.2016.04.037. Epub 2016 Apr 30.
PMID: 27160813
responsible party type: Principal Investigator
investigator affiliation: Northwell Health
investigator full name: John Pellerito
investigator title: Vice Chair, Education Department of Radiology
mesh term: Infertility
mesh term: Infertility, Female
sharing ipd: No
provided document: 
provided document: 