NCT00730886

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: InSightec · Industry
• Sex: Female
• Age: 21 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Uterine Fibroids, With Unexplained Infertility

Interventions

Type	Name	Description
DEVICE	ExAblate 2000	Magnetic resonance image guided focused ultrasound (MRgFUS) for fibroid ablation
PROCEDURE	Myomectomy	Invasive surgical procedure for fibroid removal

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-07-01
• Completion: 2011-10-06
• First posted: 2008-08-08
• Last updated: 2018-08-15
• Results posted: 2018-08-15

Locations

6 sites across 1 country: United States