Uterine Fibroids, With Unexplained Infertility Clinical Trial
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
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.
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