Decentrialz logo
  • HIPAA Compliant
  • ISO 27001 Certified
Find Trials
About UsContact
Become a Volunteer+1 877 705 1914

Status:

TERMINATED

ExAblate Treatment of Uterine Fibroids for Fertility Enhancement

Lead Sponsor:

InSightec

Conditions:

Uterine Fibroids, With Unexplained Infertility

Eligibility:

FEMALE

21-40 years

Phase:

NA

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 dia...

Eligibility Criteria

Inclusion

  • 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)

Exclusion

  • 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
  • Hemolytic anemia
  • Patients with unstable cardiac status including:
  • Unstable angina pectoris on medication
  • Patients with documented myocardial infarction within six months of protocol entry
  • Congestive heart failure requiring medication (other than diuretic)
  • Patients on anti-arrhythmic drugs
  • Severe hypertension (diastolic BP \> 100 on medication)
  • Patients with cardiac pacemakers
  • 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)
  • Patients without uterine cavity distortion.
  • Male partner exclusion criteria
  • Prior use of in vitro fertilization of other assisted reproductive technology
  • Previous treatment intrauterine inseminations
  • History of chemotherapy or radiation to the abdomen or pelvis
  • History of vasovasectomy
  • History of varicocelectomy
  • History of pelvic-node dissection
  • Use of calcium-channel blocking medications

Key Trial Info

Start Date :

July 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 6 2011

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT00730886

Start Date

July 1 2008

End Date

October 6 2011

Last Update

August 15 2018

Active Locations (6)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 2 (6 locations)

1

UCLA

Los Angeles, California, United States, 90095

2

Atlanta Interventional Institute

Smyrna, Georgia, United States, 30080

3

Mayo Clinic

Rochester, Minnesota, United States, 55905

4

Duke University

Durham, North Carolina, United States, 27713