Safety and Efficacy of Sonohysterosalpingography for the Evaluation of Infertility

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.

Inclusion Criteria:

- Undergoing evaluation for infertility in the Northwell Health System

- Non-pregnant women age 18-50 years old

- Subject is not menstruating at the time of study

- Provide written informed consent and written HIPAA authorization prior to study
initiation

- Willing to comply with the specified follow-up evaluation schedule

Exclusion Criteria:

- History of active pelvic infection

- History of tubal ligation or salpingectomy

- History of adverse reaction to iodinated contrast

- Subject is pregnant

- Subject is menstruating at time of study

- Subject is unable to participate in study evaluations pre- and post-treatment