Role of the collagen scaffold in preventing intrauterine adhesion from recurrence after adhesiolysis: protocol for a multicentre, randomised, controlled, parallel-group, open-label, superiority clinical trial.

ABSTRACT:

Introduction

Intrauterine adhesions (IUAs) are one of the most common causes of uterine infertility. Hysteroscopic adhesiolysis is the primary treatment for IUA, but the rate of IUA recurrence is high in moderate to severe cases. While traditional guidelines recommend placing a non-copper stainless steel intrauterine device (IUD) into the uterine cavity after adhesiolysis to prevent readhesion, the preventive effect is uncertain. Our preliminary trials suggested that the collagen scaffold was more effective in moderate cases. This study aims to assess the efficacy and safety of a collagen scaffold versus IUD in preventing readhesion after hysteroscopic adhesiolysis in patients with moderate IUA.

Methods and analysis

This multicentre, open-label, randomised controlled trial e

SUBMITTER: Li T 

PROVIDER: S-EPMC11865767 | biostudies-literature | 2025 Feb

REPOSITORIES: biostudies-literature