ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

Stopped early · Not applicable

Conditions studied: Uterine Fibroids, With Unexplained Infertility

In brief

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.

Key facts

Study ID

NCT00730886

Run by

InSightec

People needed

2

Starts

2008-07-01

Expected to finish

2011-10-06

Last updated by the study team

2018-08-15

Who can join

Age: 21 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

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
• 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
• Patient needs to demonstrate that she has already undergone testing and counseling in a fertility clinic or other medical office.
• Male partner inclusion criteria
• Age of male partner < 55
• At least 10 million total mobile sperm on semen analysis within last 6 months
• 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)

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
• Known or suspected pelvic carcinoma or pre-malignant conditions, including sarcoma and adenomatous hyperplasia
• Dermoid cyst of the ovary anywhere in the treatment path
• Extensive abdominal scarring that cannot be avoided by redirection of the beam (e.g., due to Caesarean section or repeated abdominal surgeries)
• Undiagnosed vaginal bleeding
• Patients having a contraindication to pregnancy.
• Patients having a contraindication to surgery, including surgical myomectomy
• Patients with type 0 submucosal fibroids.
• More than 4 clinically significant fibroids >2cm in mean diameters
• Patients on dialysis.
• Hematocrit < 25

Where it is running

• UCLA — Los Angeles, California, United States
• Atlanta Interventional Institute — Smyrna, Georgia, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Duke University — Durham, North Carolina, United States
• Willowbend Health and Wellness — Plano, Texas, United States
• University of Virginia Health System — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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