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

May 20, 2026 updated by: Xu dabao, The Third Xiangya Hospital of Central South University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients clinically diagnosed with intrauterine adhesions and with surgical indications (referring to those with fertility requirements or obstructed menstrual blood drainage) ② Women aged 20-40 years old; ③ Subjects voluntarily participated in the trial and signed informed consent.

Exclusion Criteria:

  • ① Patients with obviously abnormal uterine cavity shape after surgery; those who could not clearly separate the normal uterine cavity anatomical morphology (i.e. bilateral or unilateral fallopian tube openings were not visible); those with reproductive organ malformations and uterine cavities that were too large or too small; those with recent uterine perforation; those with cervical insufficiency.

    • Those with a history of intrauterine adhesions and treatment;

      • Those with endometrial tuberculosis or suspected endometrial tuberculosis;

        • Those with adenomyosis or uterine fibroids>4cm;

          • Those with a history of malignant tumors or suspected malignant tumors;

            • Those with acute and chronic intrauterine infection and genital infection;

              • Those with unexplained vaginal bleeding or suspected uterine malignant lesions;

                • Those with severe anemia and abnormal coagulation function; those with a history of thrombosis; ⑨ Those in the acute stage of various diseases or severe systemic diseases;

                  • Those with severe mental illness and physical weakness who cannot tolerate this operation;

                    ⑪ Those with severe heart, liver, and kidney function diseases;

                    ⑫ Those with contraindications to anesthesia or surgery;

                    ⑬ Those who have participated in clinical trials in the past three months.

                    • Those who are considered unsuitable for inclusion by the researchers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery
Device: Uterine stent group
After TCRA, uterine stents of different specifications were placed in the uterine cavity according to the different uterine cavity morphologies of the subjects, and the hysteroscope was inserted again to adjust the position of the uterine stent.
Experimental: Control group
Uterine cavity insertion ring + balloon + sodium hyaluronate gel
Device: Uterine ring + balloon + sodium hyaluronate gel
The subjects were hospitalized for TCRA surgery. After the surgery, different types of uterine rings were selected and inserted into the uterine cavity according to the morphology of the subjects' uterine cavity. At the same time, a No. 12 Foley catheter was left in the uterine cavity, and 2.5 ml of normal saline was injected into the catheter balloon. 2 ml of hyaluronic acid gel was injected into the uterine cavity on one side of the catheter. The doctor removed the Foley catheter on the first day after the surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intrauterine adhesion rate
Time Frame: At 12 months after the index hysterectomy
Refer to the 2017 American Fertility Association IUA guidelines AFS score. AFS score: The case with adhesion whose total AFS score decreased by ≥ 4 points was considered effective. The effective rate was calculated using the following formula: number of cases with total AFS score decreased by ≥ 4 points/total number of cases × 100%.
At 12 months after the index hysterectomy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Third Xiangya Hospital of Central South University

Collaborators

Beijing Tiantan Hospital
The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine
Hunan Haokang Medical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2031

Study Registration Dates

First Submitted

February 11, 2026

First Submitted That Met QC Criteria

May 20, 2026

First Posted (Actual)

May 28, 2026

Study Record Updates

Last Update Posted (Actual)

May 28, 2026

Last Update Submitted That Met QC Criteria

May 20, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XY3-QX-ZGZ-1711A02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Intrauterine Adhesion

Clinical Trials on Uterine stent group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe