A randomized, controlled clinical trial comparing the effects of aromatase inhibitor (letrozole) and gonadotropin-releasing hormone agonist (triptorelin) on uterine leiomyoma volume and hormonal status.

OBJECTIVE: To examine and compare the efficacy and safety of GnRH agonist (GnRHa) vs. aromatase inhibitor in premenopausal women with leiomyomas. DESIGN: Multicenter, randomized, controlled clinical trial. SETTING: University hospitals. PATIENT(S): A total of 70 subjects with a single uterine myoma measuring >or=5 cm. Subjects were randomized into two groups with use of a random table. They were treated with aromatase inhibitor (group A) or GnRHa (group B). INTERVENTION(S): Group A received letrozole (2.5 mg/d) for 12 weeks. Group B received triptorelin (3.75 mg/mo) for 12 weeks. MAIN OUTCOME MEASURE(S): Measurement of myoma volume and E(2), FSH, LH, and T levels. RESULT(S): Total myoma volume decreased by 45.6% in group A and 33.2% in group B. Reductions in myoma volume in the two groups were statistically significant. There was no significant change in hormonal milieu in group A. The serum level of hormones significantly decreased in group B by the 12th week of treatment. CONCLUSION(S): Uterine myoma volume was successfully reduced by use of an aromatase inhibitor. Rapid onset of action and avoidance of initial gonadotropin flare with an aromatase inhibitor may be advantageous for short-term management of women with myomas of any size who are to be managed transiently and who wish to avoid surgical intervention, specifically women with unexplained infertility having uterine myoma.

Hysteroscopic metroplasty of the complete uterine septum, duplicate cervix, and vaginal septum.

OBJECTIVE: To determine if sectioning of the cervical septum in hysteroscopic metroplasty of the complete uterine septum is associated with intraoperative bleeding, cervical incompetence, and secondary infertility. DESIGN: Multicenter, randomized, controlled clinical trial. SETTING: University hospitals. PATIENT(S): Twenty-eight women with a diagnosis of complete uterine septum who had a history of pregnancy wastage or infertility. They were randomized into two groups: group A underwent metroplasty including section of the cervical septum; group B underwent the same procedure with preservation of the cervical septum. INTERVENTION(S): Hysteroscopic metroplasty was performed for all patients in the two groups. MAIN OUTCOME MEASURE(S): Operating time, distending media deficit, total distending media used, intraoperative bleeding, complications, and reproductive outcome. RESULT(S): Operating times were 36.40 +/- 10.67 minutes and 73 +/- 14.40 minutes in group A and group B, respectively. Distending media deficit was 456.66 +/- 165.68 mL in group A, while in group B it was 673.84 +/- 220.36. Two cases of pulmonary edema and three cases of significant bleeding (> 150 mL) were seen in group B. The cesarean section rate was significantly higher in group B. There were no significant differences in the reproductive outcome in the two groups. CONCLUSION(S): Resection of the cervical septum during hysteroscopic metroplasty of complete uterine septum makes the procedure safer, easier, and less complicated than the procedure with preservation of the cervical septum. This procedure is recommended for all cases of complete uterine septum.