Effect of collagen scaffold versus intrauterine device on preventing recurrence of intrauterine adhesions: a multicenter randomized controlled trial.

Abstract

OBJECTIVE To evaluate the efficacy of collagen scaffold versus intrauterine device (IUD) in prevention of adhesion recurrence in moderate intrauterine adhesions (IUA) following hysteroscopic adhesiolysis. DESIGN A multicenter, open-label, randomized controlled, two-arm superiority clinical trial. SETTING Six tertiary university hospitals from February 2023 to September 2024. SUBJECTS Participants aged 20-40 years with moderate IUAs (based on American Fertility Society [AFS] score 5-8) planned to accept hysteroscopic adhesiolysis. INTERVENTION Participants were randomly allocated to collagen scaffold group or IUD group (1:1) and received hormonal therapy after surgery. A second-look hysteroscopy (SLH) was scheduled at 2 months after the adhesiolysis. MAIN OUTCOME The primary outcome was the rate of no IUA recurrence at SLH. The secondary outcomes included AFS score at SLH, decrease of AFS score at SLH, and menstrual pattern improvement at 1-month and 2-month post-operation. RESULTS A total of 195 patients were randomized to collagen scaffold group (n = 98) or IUD group (n = 97). The rate of no IUA recurrence at SLH in collagen scaffold group was significantly higher than that in IUD group (78.6% vs. 58.8%; risk ratio, 1.4; 95% confidence interval, 1.1-1.6; P=0.003). There was no significant difference in AFS score and decrease of AFS score at SLH between the two groups. The incidence of adverse events did not differ between the two groups and no serious adverse events were reported. CONCLUSION Collagen scaffold is superior to IUD in preventing adhesion recurrence after hysteroscopic adhesiolysis in moderate IUAs.