Effectiveness of degradable polymer film in the management of severe or moderate intrauterine adhesions (PREG-2): a randomised, double blind, multi-centre, stratified, superiority trial.

Abstract

To study the effectiveness of a new intrauterine degradable polymer film (Womed Leaf®) in the management of moderate to severe IUA. PREG2 study was a multi-centre, double-blind, randomised, controlled, stratified, two-arm superiority clinical trial conducted in 16 centres in 7 countries. Patients ≥18 years scheduled for hysteroscopic adhesiolysis because of symptomatic severe or moderate adhesions (according to American fertility society (AFS) IUA score) were considered eligible for the study. Following adhesiolysis, patients were randomised at a 1:1 ratio to either have a Womed Leaf film inserted (intervention group) or not (control group). The primary effectiveness endpoint of the study was the change in AFS IUA score on second-look hysteroscopy (SLH), assessed by an independent evaluator, compared to baseline. Information on rate of no IUA and responder rate were collected as secondary effectiveness outcomes, and reported adverse events and patient reported outcomes as safety and tolerability measures. Between October 26, 2021, and September 28, 2023, a total of 160 women were randomised (Womed Leaf: n=75 and controls: n=85). The reduction in IUA AFS score on SLH was significantly higher in the intervention compared to the control group (mean 5.2 ± 2.8 vs. 4.2 ± 3.2; p=0.0153). Similarly, the absence of adhesions on SLH was significantly higher in the intervention group (41% vs 24% OR 2.44 [CI 1.161 - 5.116]; p=0.0189). None of the reported adverse events were serious or considered related to the device. Womed Leaf is effective and safe in the management of symptomatic severe or moderate intrauterine adhesions.