GnRHa vs. observation in the treatment of multiple leiomyomas after myomectomy: study protocol for a multicenter, prospective, randomized controlled clinical trial

Background: Recurrence of the leiomyoma is one of the major concerns of myomectomy in the long-term management, especially for the multiple leiomyomas. Gonadotropin-releasing hormone agonist (GnRHa) is currently one of the most effective medications to reduce the volume of the fibroids and the uterus. However, its role in preventing recurrence after conservative surgery remains unclear. At present, there is no evidence from randomized clinical trials comparing the efficacy between GnRHa and follow-up observation in the recurrence rate of multiple leiomyomas after myomectomy.Methods: We are conducting a randomized controlled trial in women aged 18-45 undergoing myomectomy for the multiple leiomyomas. After the surgery, women whose pathological result confirms multiple leiomyoma are randomized into two parallel groups: observation group and GnRHa group. The primary outcome is the recurrence of either clinical symptoms or imaging.Discussion: The results of this study will provide evidence for the efficacy of the gonadotropin-releasing hormone agonist in preventing the recurrence of high-risk leiomyoma after myomectomy.Trial registration: Chinese Clinical Trial Registry, ChiCTR-IPR-17012992 (http://www.chictr.org.cn/showproj.aspx?proj=21797 ). Registered on 15 Oct 2017.