A Novel Intrauterine Estrogen-Releasing System for Preventing the Postoperative Recurrence of Intrauterine Adhesion: A Multicenter Randomized Controlled Study

Abstract

Background Transcervical resection of adhesions (TCRA) is the standard treatment for intrauterine adhesion (IUA). Previous studies have shown that postoperative oral estrogen or an intrauterine physical barrier could reduce the recurrence of IUA by promoting the proliferation of the endometrium or inhibiting the reformation of adhesions. Our team designed an intrauterine stent that can slowly release estrogen within the uterine cavity. In this study, we aimed to investigate the efficacy and safety of the estrogen-releasing intrauterine system in preventing the recurrence of moderate to severe IUAs. Methods This was a prospective randomized controlled multicenter 2-arm parallel trial that included patients who were diagnosed with moderate to severe IUA and who received TCRA. A total of 250 patients were randomly assigned, at a 1:1 ratio, to receive the intrauterine estrogen-releasing system or a Foley catheter balloon combined with oral estrogen therapy after surgery. The primary outcome was the rate of adhesion remission in the two groups. The secondary outcomes included endometrial thickness at the period of ovulation, menstrual improvement rates, serum estradiol levels, pregnancy rates, and other reported adverse events during follow-up. t test, chi-squared, Fisher’s exact probability tests and Cochran-Mantel-Haenszel test were used to assess the data in this research. Results At 60 days postoperatively, the rate of adhesion reduction was significantly greater in the experimental group than in the control group (93.33% vs. 58.56%, P<0.001). The endometrium of the experimental group was thicker than that of the control group (p<0.001). Consistently, the rate of improvement in menstruation was greater in the experimental group than in the control group (p=0.010). No grade 3-4 adverse events were found in the two groupsduring the one-year follow-up. Conclusion In the cohort of patients with moderate to severe IUA, the intrauterine estrogen-releasing system was more effective at reducing adhesion than traditional oral estrogen combined with an intrauterine Foley catheter after TCRA. This novel intrauterine system provides a new option for the management of IUA after surgery. Trial registration Registration number is NCT04972032. Date of registration: August 15, 2021.