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A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy

Phase 4
21 Years
40 Years
Not Enrolling
Uterine Fibroids, With Unexplained Infertility

Thank you

Trial Information

A Randomized Study to Evaluate the Effectiveness and Safety of ExAblate Surgery Compared With Myomectomy for the Enhancement of Fertility Following Treatment of Uterine Fibroids in Women Seeking Pregnancy

Inclusion Criteria:

Female Partner

1. Able and willing to give consent

2. Able to attend all study visits.

3. At least one fibroid 3.0 cm or larger which is type 2 submucosal or intramural
touching or abutting the cavity.

4. Able to communicate sensations during the ExAblate procedure.

5. Uterine fibroids, which are device accessible

6. Fibroids(s) clearly visible on non-contrast MRI. and with uniform enhancement with

7. Age 21 to 40 (patients cannot be treated following their 41st birthday)

8. Patients with uterine cavitary distortion based on MRI images or ultrasound.

9. Premenopausal status

10. Normal pap smear and/or HPV testing within institutional guidelines

11. At least one ovary and at least one ipsilateral patent fallopian tube confirmed b
hysterosalpingogram or laparoscopy.

12. Normal serum follicle-stimulating hormone and thyrotropin values on days 1-5 of the

13. Length of 2 of the 3 most recent menstrual cycles between 24 and 35 days.

14. History of trying for pregnancy for at least 6 months

15. Documentation of ovulation using urine LH testing, serum LH testing, serum
progesterone > 4 ng/dl or endometrial biopsy showing secretory endometrium in a cycle
between 24 and 35 days

16. Patient needs to demonstrate that she has already undergone testing and counseling in
a fertility clinic or other medical office.

Male partner inclusion criteria

1. Age of male partner < 55

2. At least 10 million total mobile sperm on semen analysis within last 6 months

3. Use of donor sperm which includes at least 10 million total mobile sperm, for female
candidates who otherwise meet eligibility criteria (e.g., single women, etc)

Exclusion Criteria:

1. Uterine size > 16 weeks

2. Prior surgical intervention for fibroids (including UAE) except uncomplicated
myomectomy (hysteroscopic, laparoscopic or abdominal) and MRgFUS.

3. Prior use of in vitro fertilization or other assisted reproductive technology

4. Previous treatment with gonadotropins or intrauterine inseminations

5. History of tubal surgery

6. History of oophorectomy

7. History of chemotherapy or radiation to the abdomen or pelvis

8. MRI showing only adenomyosis

9. Metallic implants that are incompatible with MRI

10. Severe claustrophobia that would prevent completion of procedure in MR unit

11. Patients with a BMI greater than 38.

12. Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) including
severe kidney disease

13. Individuals who are not able or willing to tolerate the required prolonged stationary
prone position during treatment (approximately 3 hrs.)

14. Active pelvic inflammatory disease (PID)

15. Active local or systemic infection

16. Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma
and adenomatous hyperplasia

17. Dermoid cyst of the ovary anywhere in the treatment path

18. Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g.,
due to Caesarean section or repeated abdominal surgeries)

19. Undiagnosed vaginal bleeding

20. Patients having a contraindication to pregnancy.

21. Patients having a contraindication to surgery, including surgical myomectomy

22. Patients with type 0 submucosal fibroids.

23. More than 4 clinically significant fibroids >2cm in mean diameters

24. Patients on dialysis.

25. Hematocrit < 25

26. Hemolytic anemia

27. Patients with unstable cardiac status including:

28. Unstable angina pectoris on medication

29. Patients with documented myocardial infarction within six months of protocol entry

30. Congestive heart failure requiring medication (other than diuretic)

31. Patients on anti-arrhythmic drugs

32. Severe hypertension (diastolic BP > 100 on medication)

33. Patients with cardiac pacemakers

34. Patients planning to use adjuvant therapies post (ExAblate or Myomectomy) procedures
to improve the chance of conception within 9 months of study treatment will be
excluded from study (note: candidates relying on donor sperm and artificial
insemination to conceive between months 3 and 9 post-treatment are allowed to
participate, provided they meet all eligibility criteria)

35. Patients without uterine cavity distortion.

Male partner exclusion criteria

1. Prior use of in vitro fertilization of other assisted reproductive technology

2. Previous treatment intrauterine inseminations

3. History of chemotherapy or radiation to the abdomen or pelvis

4. History of vasovasectomy

5. History of varicocelectomy

6. History of pelvic-node dissection

7. Use of calcium-channel blocking medications

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Live birth rate

Outcome Time Frame:

Between the 3 and 9-month post-treatment visits

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • Uterine Fibroids, With Unexplained Infertility
  • Uterine Fibroids
  • Unexplained Infertility
  • MRgFUS
  • ExAblate
  • Focused Ultrasound
  • Myomectomy
  • Infertility
  • Leiomyoma
  • Myofibroma



Mayo ClinicRochester, Minnesota  55905
Duke UniversityDurham, North Carolina  27710
UCLALos Angeles, California  90095
University of Virginia Health SystemCharlottesville, Virginia  22903
Atlanta Interventional InstituteSmyrna, Georgia  30080
Willowbend Health and WellnessPlano, Texas  75093