IRB Number:

08-003276

Trial Status:

Open for Enrollment

Phase: IV

Why is this study being done?

The purpose of this study is to see if a less invasive way of treating uterine fibroids that appear to be causing infertility is as safe and effective as the standard surgery to remove the fibroids. A device called ExAblate, which is approved for fibroid treatment in women not desiring fertility, will be compared to the standard surgical procedure for removal of fibroids called myomectomy. ExAblate works by destroying uterine fibroids with sound waves and heat in a process called Magnetic Resonance Guided Focused Ultrasound Surgery (MRgFUS). Both groups will have their uterine fibroids treated. One group will receive the experimental ExAblate treatment. The other group will receive an approved surgical treatment for removal of fibroids called myomectomy.

Who is Eligible to Participate in the Study?

Women who have fibroids pressing on the inside of the uterus and who are trying to get pregnant may be eligible if:
-- They have been trying to get pregnant for at least 6 months
-- Their partner has a good sperm count
-- They are ovulating(producing an egg regularly)
-- They have open fallopian tubes

Minimum Age:

21

Maximum Age:

40

What is Involved With this Study?

If you are eligible to participate in the study, you will be put in one of two groups by chance (as in the flip of a coin). This is called randomization. Since your treatment (ExAblate or myomectomy) will be assigned by chance, you will not be able to choose between the experimental ExAblate treatment and myomectomy. You will have an equal chance (50/50) of being in either the ExAblate treatment group or of receiving a myomectomy. You will be followed for 4 years following treatment to record any pregnancy. In addition, you will be asked to complete five questionnaires about your general health, your fibroid symptoms, depression, and health care costs. The questionnaires will take approximately 20 minutes to complete.

How long will the Study run?

You will be actively followed for one year after your fibroid treatment. Phone follow-up for this study may be ongoing an additional four years, for a total of five years participation.

Who can I Contact for Additional Information on this Trial?

Lisa G. Peterson, BSN, RN
Study Coordinator
Clinical Research Office
Department of Obstetrics and Gynecology
Phone: 507-266-4813.

What is/are the Locations of this Clinical Trial?

• Rochester, MN

Last updated: 06/23/2009