ExAblate Treatment of Uterine Fibroids for Fertility Enhancement
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
1 other identifier
interventional
2
1 country
6
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2008
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2008
CompletedFirst Submitted
Initial submission to the registry
August 5, 2008
CompletedFirst Posted
Study publicly available on registry
August 8, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 6, 2011
CompletedResults Posted
Study results publicly available
August 15, 2018
CompletedAugust 15, 2018
August 1, 2018
3 years
August 5, 2008
July 13, 2018
August 13, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Live Birth Rate
Between the 3 and 9-month post-treatment visits
Secondary Outcomes (9)
Pregnancy Rate
Between the 3 and 15-month post-treatment visits
Term Delivery Rate
Between the 3 and 15-month post-treatment visits
Miscarriage Rate
Between the 3 and 15-month post-treatment visits
Time to Conception
Post-treatment
C-Section Rate
Post-treatment
- +4 more secondary outcomes
Study Arms (2)
1
EXPERIMENTALNon-invasive procedure for fertility enhancement (i.e., ExAblate treatment)
2
ACTIVE COMPARATORInvasive surgical procedure for fertility enhancement (i.e., myomectomy)
Interventions
Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
Eligibility Criteria
You may qualify if:
- Female Partner
- Able and willing to give consent
- Able to attend all study visits.
- At least one fibroid 3.0 cm or larger which is type 2 submucosal or intramural touching or abutting the cavity.
- Able to communicate sensations during the ExAblate procedure.
- Uterine fibroids, which are device accessible
- Fibroids(s) clearly visible on non-contrast MRI. and with uniform enhancement with gadolinium
- Age 21 to 40 (patients cannot be treated following their 41st birthday)
- Patients with uterine cavitary distortion based on MRI images or ultrasound.
- Premenopausal status
- Normal pap smear and/or HPV testing within institutional guidelines
- At least one ovary and at least one ipsilateral patent fallopian tube confirmed b hysterosalpingogram or laparoscopy.
- Normal serum follicle-stimulating hormone and thyrotropin values on days 1-5 of the cycle
- Length of 2 of the 3 most recent menstrual cycles between 24 and 35 days.
- History of trying for pregnancy for at least 6 months
- +5 more criteria
You may not qualify if:
- Uterine size \> 16 weeks
- Prior surgical intervention for fibroids (including UAE) except uncomplicated myomectomy (hysteroscopic, laparoscopic or abdominal) and MRgFUS.
- Prior use of in vitro fertilization or other assisted reproductive technology
- Previous treatment with gonadotropins or intrauterine inseminations
- History of tubal surgery
- History of oophorectomy
- History of chemotherapy or radiation to the abdomen or pelvis
- MRI showing only adenomyosis
- Metallic implants that are incompatible with MRI
- Severe claustrophobia that would prevent completion of procedure in MR unit
- Patients with a BMI greater than 38.
- Known intolerance to the MRI contrast agent (e.g. Gadolinium or Magnevist) including severe kidney disease
- Individuals who are not able or willing to tolerate the required prolonged stationary prone position during treatment (approximately 3 hrs.)
- Active pelvic inflammatory disease (PID)
- Active local or systemic infection
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- InSighteclead
Study Sites (6)
UCLA
Los Angeles, California, 90095, United States
Atlanta Interventional Institute
Smyrna, Georgia, 30080, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Duke University
Durham, North Carolina, 27713, United States
Willowbend Health and Wellness
Plano, Texas, 75093, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (3)
Hanstede MM, Tempany CM, Stewart EA. Focused ultrasound surgery of intramural leiomyomas may facilitate fertility: a case report. Fertil Steril. 2007 Aug;88(2):497.e5-7. doi: 10.1016/j.fertnstert.2006.11.103. Epub 2007 Feb 8.
PMID: 17292361BACKGROUNDRabinovici J, David M, Fukunishi H, Morita Y, Gostout BS, Stewart EA; MRgFUS Study Group. Pregnancy outcome after magnetic resonance-guided focused ultrasound surgery (MRgFUS) for conservative treatment of uterine fibroids. Fertil Steril. 2010 Jan;93(1):199-209. doi: 10.1016/j.fertnstert.2008.10.001. Epub 2008 Nov 14.
PMID: 19013566BACKGROUNDBouwsma EV, Gorny KR, Hesley GK, Jensen JR, Peterson LG, Stewart EA. Magnetic resonance-guided focused ultrasound surgery for leiomyoma-associated infertility. Fertil Steril. 2011 Jul;96(1):e9-e12. doi: 10.1016/j.fertnstert.2011.04.056. Epub 2011 May 13.
PMID: 21570071DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
enrollment in the clinical trial did not reach the target number of subjects needed to achieve target power and was insufficient to produce statistically reliable results.
Results Point of Contact
- Title
- Nadir Alikacem
- Organization
- InSightec
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2008
First Posted
August 8, 2008
Study Start
July 1, 2008
Primary Completion
July 1, 2011
Study Completion
October 6, 2011
Last Updated
August 15, 2018
Results First Posted
August 15, 2018
Record last verified: 2018-08