Abstract
Objective: To determine if three months of chronic daily administration of ulipristal acetate (UPA), a selective progesterone receptor modulator, normalized the uterine cavity in women with leiomyoma. Methods: Saline sonograms with abnormal uterine cavities from patients participating in a placebo controlled double blind randomized controlled trial evaluating UPA effect on leiomyoma volume were identified prior to initiation of therapy. They were reexamined after 12 weeks of UPA therapy. Normal uterine cavity was defined as having zero percent of leiomyoma volume inside the cavity on repeat sonohysterography. Patients with normal saline sonograms after 12 weeks of UPA therapy were compared with patients with sonographically persistently abnormal uterine cavities. Statistical analysis was performed using the Fisher’s exact test. Results: 28 patients had abnormal sonohysterogram results at baseline (n= 9, n= 8 and n=11 for placebo, UPA 10 mg and UPA 20 mg respectively). At the end of treatment 22% of the placebo group, 38% of the 10 mg group and 27% of the 20 mg group had normal uterine cavities. When the 10 mg and 20 mg groups were combined, 32% of the patients had normal uterine cavities post treatment. The results did not reach statistical significance. Conclusion: If future larger, randomized trials demonstrate a benefit, UPA may offer an alternative to surgical therapy for women requiring normalization of the uterine cavity.
Highlights
A number of studies, including a prior investigation by our group, have shown that women with fibroids have lower incidence of pregnancy when undergoing treatment with Assisted Reproductive Technologies (ART) [1,2,3,4]
Approved pharmacological therapy for uterine leiomyoma is limited to gonadotropin releasing hormone (GnRH) agonists
Effective pharmacologic therapy is unavailable for this purpose and these patients are subjected to additional surgical intervention in the form of hysteroscopy, laparoscopy or laparotomy to normalize the uterine cavity prior to proceeding with ART
Summary
A number of studies, including a prior investigation by our group, have shown that women with fibroids have lower incidence of pregnancy when undergoing treatment with Assisted Reproductive Technologies (ART) [1,2,3,4]. It is accepted clinical practice to offer surgical correction of the uterine cavity prior to treatment with ART. Approved pharmacological therapy for uterine leiomyoma is limited to gonadotropin releasing hormone (GnRH) agonists. This therapy is hindered by its transient effect as leiomyomas typically return to pre treatment size. This has limited GnRH agonists to primarily function as presurgical adjunct therapy to minimize operative difficulty. Effective pharmacologic therapy is unavailable for this purpose and these patients are subjected to additional surgical intervention in the form of hysteroscopy, laparoscopy or laparotomy to normalize the uterine cavity prior to proceeding with ART. Most recent, comprehensive review of the literature failed to provide a definitive answer regarding whether myomectomy was beneficial [6]
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