ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
InSightec
ClinicalTrials.gov Identifier:
NCT00730886
First received: August 5, 2008
Last updated: September 13, 2012
Last verified: September 2012
  Purpose

The objective of this trial is to evaluate the efficacy and safety of the ExAblate 2000 system for enhancement of fertility in women with non-hysteroscopically resectable uterine fibroids, who are diagnosed with unexplained infertility.

Uterine fibroids are fairly common in women of child-bearing age. An evidence based review supported removing fibroids that distort the uterine cavity to increase pregnancy rates and decrease the rates of miscarriage. Some fibroids can be removed hysteroscopically which is minimally invasive, with low morbidity. However, removal of fibroids within the uterine wall require more invasive surgical procedures (e.g., myomectomy), with increasing morbidity risks including, but not limited to, infection, blood loss and postoperative uterine adhesions.

ExAblate is approved by FDA for the treatment of uterine fibroids; however, its use in patients seeking pregnancy is considered experimental. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy as with existing fibroid therapies; however, these data are based on a small number of patients. This study will evaluate fertility enhancement following ExAblate treatment or myomectomy, in women with unexplained infertility and who have non-hysteroscopically resectable uterine fibroids.


Condition Intervention Phase
Uterine Fibroids, With Unexplained Infertility
Device: ExAblate 2000
Procedure: Myomectomy
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by InSightec:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: Between the 3 and 9-month post-treatment visits ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pregnancy rate [ Time Frame: Between the 3 and 15-month post-treatment visits ] [ Designated as safety issue: No ]
  • Term delivery rate [ Time Frame: Between the 3 and 15-month post-treatment visits ] [ Designated as safety issue: No ]
  • Miscarriage rate [ Time Frame: Between the 3 and 15-month post-treatment visits ] [ Designated as safety issue: No ]
  • Time to conception [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • C-Section rate [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-Item Short Form Survey [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]
  • Health Care Costs [ Time Frame: Post-treatment ] [ Designated as safety issue: No ]

Enrollment: 2
Study Start Date: July 2008
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Non-invasive procedure for fertility enhancement (i.e., ExAblate treatment)
Device: ExAblate 2000
Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
Active Comparator: 2
Invasive surgical procedure for fertility enhancement (i.e., myomectomy)
Procedure: Myomectomy
Invasive surgical procedure for fibroid removal

  Eligibility

Ages Eligible for Study:   21 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 gadolinium
  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 cycle
  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00730886

Locations
United States, California
UCLA
Los Angeles, California, United States, 90095
United States, Georgia
Atlanta Interventional Institute
Smyrna, Georgia, United States, 30080
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, North Carolina
Duke University
Durham, North Carolina, United States, 27713
United States, Texas
Willowbend Health and Wellness
Plano, Texas, United States, 75093
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
InSightec
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: InSightec
ClinicalTrials.gov Identifier: NCT00730886     History of Changes
Other Study ID Numbers: UF023
Study First Received: August 5, 2008
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by InSightec:
Uterine Fibroids
Unexplained Infertility
MRgFUS
ExAblate
Focused Ultrasound
Myomectomy

Additional relevant MeSH terms:
Infertility
Leiomyoma
Myofibroma
Genital Diseases, Male
Genital Diseases, Female
Neoplasms, Muscle Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Connective Tissue
Connective Tissue Diseases

ClinicalTrials.gov processed this record on July 22, 2014