Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): sonoHSG
Intervention type(s): Procedure
Intervention description(s): 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.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: sonohysterosalpingography; hysterosalpingography