To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial

To evaluate the effect of uterine stents in preventing intrauterine adhesions after intrauterine operation and whether they meet the safety requirements for clinical use. The trial adopted a prospective, multicenter, randomized controlled, non-inferiority clinical trial design. The target population of the trial was 200 women aged 20-40 years with intrauterine adhesions and surgical indications (referring to those with fertility requirements or menstrual blood drainage obstruction), who were randomly divided into an experimental group and a control group, with 100 cases in each group. The experimental group was the group with intrauterine stents placed in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery, and the control group was the group with intrauterine rings + balloons + sodium hyaluronate gel placed in the uterine cavity. After 3 courses of artificial cycles, the patients were hospitalized for hysteroscopy review.

NCT Number	NCT07611474
Lead Sponsor	The Third Xiangya Hospital of Central South University Collaborators: Hunan Haokang Medical Technology Co., Ltd., Beijing Tiantan Hospital, The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Conditions	Intrauterine Adhesion, Intrauterine Adhesions
Enrollment	200 participants
Start Date	2021-01-01
Primary Completion	2026-12-31 (estimated)
Study Completion	2031-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-28