Hysterosalpingo-foam sonography as an Essure confirmation test

Plain English summary of protocol

Background and study aims
Essure is a permanent birth control method for women. Implantation of Essure does not require a surgical incision. In the procedure, Essure micro-inserts are inserted through the vagina and cervix and into the fallopian tubes. Over a period of three months, tissue forms around the micro-inserts, which blocks the fallopian tubes and creates a barrier that keeps sperm from reaching the eggs, thus preventing conception. Women need to use additional birth control in the first three months following the procedure, after which micro-insert position or fallopian tube occlusion (blocking) should be checked by a confirmation test. Confirmation tests currently vary from country to country. In Slovenia, vaginal ultrasound (US) is performed three months after the procedure to assess the micro-insert position, which is defined as correct, indeterminate or incorrect. In cases with indeterminate or incorrect micro-insert position, a tubal patency test is performed. Hysterosalpingography (HSG) has been the gold standard for such confirmation: a radiographic contrast material is injected into the womb to detect the closure of the fallopian tubes by X-ray. Because of the potential adverse effect of HSG, alternative methods have been suggested to verify the position of the micro-inserts or the tubal occlusion. Ultrasound assessment, however, is the least invasive method of all. The use of ultrasound with contrast material – hysterosalpingo-contrast sonography (HyCoSy), has been used for checking the patency of the fallopian tube in the past, but this contrast material is no longer available for gynaecological use. Recently, ExEm foam was introduced as a contrast medium for contrast sonography – hysterosalpingo-foam sonography (HyFoSy), which is a safe and a successful procedure to demonstrate tubal patency as a first step procedure in patients with troubles in conceiving a child (subfertility). In this study, the US, HSG and HyFoSy findings in patients after Essure sterilization are compared. How US findings correlate with tubal blockage on HSG are compared. This study also investigates if HyFoSy, which is a less invasive procedure than HSG, is as successful as HSG in determinating the tubal blockage. The study's findings could change the confirmation test protocol for women after Essure sterilization.

Who can participate?
Women aged 35 to 50 years old that are undergoing Essure hysteroscopic sterilization for pregnancy prevention at University Medical Centre Maribor, Slovenia.

What does the study involve?
Essure hysteroscopic sterilization is performed, by which Essure micro-inserts are put into the fallopian tubes through the vagina and cervix. Twelve weeks after the procedure all patients have three confirmation tests, where micro-insert position and tubal occlusion are assessed. US is performed to assess the micro-insert position. Then both HyFoSy and HSG are performed to assess tubal patency. At HyFoSy, tubal patency is tested with the use of vaginal ultrasound by injecting ExEm foam into the womb though vagina. At HSG, tubal patency is tested by X-ray by injecting Iopamiro radiographic contrast medium into the womb through vagina. Questionnaires are filled in by the patients and the researchers. At the end of the study, the researchers compare how US findings correlate with tubal blockage on HSG and if HyFoSy is as successful as HSG in confirming the tubal blockage.

What are the possible benefits and risks of participating?
There will be no immediate direct benefit to those taking part. But there should be benefits to future patients referred to the Essure hysteroscopic sterilization because the results of the study may have an influence on the confirmation test protocol after Essure sterilization. Side effects of the Essure procedure are rare, but include incorrect placement of micro-inserts and perforation of the womb or the fallopian tube. In these instances, surgery may be needed to repair the damage of the tissue. Some women experience nausea, vomiting or fainting. Pain, cramping, vaginal bleeding, and pelvic or back discomfort can be present for a few days after the procedure. In very rare instances, an Essure micro-insert may be expelled from the body. Long term side effects of the Essure procedure include chronic pelvic pain and migration of the micro-insert into the lower abdomen and pelvis. If this happens, it may be necessary to surgically remove the micro-insert. No birth control method is 100% effective. There is a very small chance that women become pregnant after completing the Essure procedure, and if so, they are more likely to have a pregnancy outside the womb (ectopic pregnancy). The Essure micro-insert is made of materials that include a nickel-titanium alloy. Patients who are allergic to nickel may have an allergic reaction to the inserts. Symptoms include rash, itching and hives. There are no risks during US examination. Because HSG requires an X-ray, women are exposed to very low levels of radiation. Other risks of HSG are similar to the risks of HyFoSy. They are rare and include allergy, pain, fainting, spotting and infection.

Where is the study run from?
University Medical Centre Maribor, Slovenia.

When is study starting and how long is it expected to run for?
January 2013 to June 2016

Who is the main contact?
Maja Rosic, MD

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• Slovenia

Study participating centre

Sponsor information

University Medical Centre Maribor
Hospital/treatment centre

Ljubljanska 5
Maribor
2000
Slovenia

Website	www.ukc-mb.si
"ROR"	https://ror.org/02rjj7s91

Funders

Funder type

Hospital/treatment centre

Results and Publications

Study outputs

Editorial Notes

29/01/2019: Publication reference added