Can SIS Using Air Bubbles Replace HSG for Fallopian Tubal Patency After Essure Placement
| Status: | Terminated |
|---|---|
| Conditions: | Contraception, Contraception |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/5/2018 |
| Start Date: | December 2015 |
| End Date: | October 2018 |
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.
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.
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.
Inclusion Criteria:
- Documentation of normal Pap smear within 1 year prior to enrollment into study.
- Written informed consent given
- Need for evaluation of tubal status for post-Essure tubal occlusion
- Negative urine pregnancy test
Exclusion Criteria:
- History of unresolved dysfunctional uterine bleeding (DUB).
- History of a hysterectomy.
- Current urogenital disease.
- History of allergic response to IVP dye (exclusion for HSG).
- Abnormal pap smear.
- Positive urine pregnancy test.
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