Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
This study is currently recruiting participants.
Verified by InSightec, January 2009
Sponsored by: InSightec
Information provided by: InSightec
ClinicalTrials.gov Identifier: NCT00730886
  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 a non-invasive FDA-approved treatment for uterine fibroids. Accumulated evidence suggests there are no significant complications from the procedure in women seeking pregnancy, as with existing fibroid therapies. 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 IV

MedlinePlus related topics: Infertility Ultrasound
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by InSightec:

Primary Outcome Measures:
  • Live birth rate [ Time Frame: Between the 3 and 15-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: Pre-treatment and through 15-month post-treatment visit ] [ Designated as safety issue: No ]
  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Pre-treatment and through 15-month post-treatment visit ] [ Designated as safety issue: No ]
  • Medical Outcomes Study 36-Item Short Form Survey [ Time Frame: Pre-treatment and through 15-month post-treatment visit ] [ Designated as safety issue: No ]
  • Health Care Costs [ Time Frame: Pre-treatment and through 15-month post-treatment visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 650
Study Start Date: July 2008
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Non-invasive procedure for fertility enhancement (i.e., ExAblate treatment)
Device: ExAblate 2000
Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
2: Active Comparator
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 37 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 37 (patients cannot be treated following their 38th 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. Hysterosalpingogram with open fallopian tubes
  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

Exclusion Criteria:

  1. Uterine size > 16 weeks
  2. Prior surgical intervention for fibroids (myomectomy, UAE, or 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 30.
  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 pedunculated fibroid(s)
  23. More than 4 fibroids
  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 adjunctive therapies post (ExAblate or Myomectomy) procedures to improve the chance of conception will be excluded from study
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00730886

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Lisa Peterson, RN     507-266-4813     peterson.lisa@mayo.edu    
Principal Investigator: Elizabeth Stewart, MD            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27713
Contact: Meredith Smith, RN     919-572-8851     Meredith.A.Smith@duke.edu    
United States, Texas
Willowbend Health and Wellness Recruiting
Plano, Texas, United States, 75093
Contact: Natalie Settele, PA-C     469-361-4007     nsettelepa@phyllisgeemd.com    
Principal Investigator: Phyllis J Gee, MD            
United States, Washington
Focused Ultrasound Northwest Recruiting
Renton, Washington, United States, 98057
Contact: Lori McMann     425-251-3138     lori@idcwest.com    
Principal Investigator: Eric N Fassler, MD            
Sponsors and Collaborators
InSightec
  More Information

Sponsor's Web Page  This link exits the ClinicalTrials.gov site

Publications:
Responsible Party: InSightec ( InSightec )
Study ID Numbers: UF023
Study First Received: August 5, 2008
Last Updated: January 12, 2009
ClinicalTrials.gov Identifier: NCT00730886  
Health Authority: United States: Food and Drug Administration

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

Study placed in the following topic categories:
Genital Diseases, Female
Neoplasms, Connective and Soft Tissue
Infertility
Myofibroma
Connective Tissue Diseases
Genital Diseases, Male
Leiomyoma

Additional relevant MeSH terms:
Neoplasms, Muscle Tissue
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective Tissue

ClinicalTrials.gov processed this record on January 16, 2009