Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
InSightec |
---|---|
Information provided by: | InSightec |
ClinicalTrials.gov Identifier: | NCT00730886 |
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 |
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 |
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
|
Ages Eligible for Study: | 21 Years to 37 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Female Partner
Male partner inclusion criteria
Exclusion Criteria:
Male partner exclusion criteria
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 |
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 |
Uterine Fibroids Unexplained Infertility MRgFUS |
ExAblate Focused Ultrasound Myomectomy |
Genital Diseases, Female Neoplasms, Connective and Soft Tissue Infertility Myofibroma |
Connective Tissue Diseases Genital Diseases, Male Leiomyoma |
Neoplasms, Muscle Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue |