Contraception Clinical Trial
Official title:
Can Contrast Infused Sonography Using Air Bubbles Replace Hysterosalpingogram as the Diagnostic Evaluation of Fallopian Tube Patency Following Hysteroscopic Sterilization Using Essure
The study evaluates whether saline infused sonography (SIS) with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) is as good as or better than X-ray hysterosalpingography (HSG) for determining whether fallopian tubes are open or closed in patients who are undergoing an Essure confirmation test.
The gold standard for evaluating whether fallopian tubes are open versus closed is the X-ray
hysterosalpingography (HSG). HSG is a radiologic procedure that is performed to verify that
placement of the Essure tubal ligation inserts have successfully blocked the fallopian tubes.
However, this procedure involved exposure to radiation. The saline infused sonography (SIS)
with directed air bubbles for hysterosalpingo-contrast sonography (HyCoSy) does not involve
radiation and can be done in a physician's office. The HyCoSy air bubble device may be a
lower cost, safer alternative procedure if it can be shown to provide similar results for
tubal patency.
This study will compare the HyCoSy procedure results with the HSG procedure results in women
who require the HSG procedure after receiving Essure tubal ligation inserts for their Essure
confirmation test.
Women will be randomized to receive the HycoSy procedure first, followed by the HSG procedure
or to the reverse order. Two independent readers will review the video results for both
procedures to determine the degree of agreement on tubal patency.
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