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

NCT07611474 | Recruiting

• 1 other identifier: XY3-QX-ZGZ-1711A02
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intrauterine Adhesion; Intrauterine Adhesions

Outcome Measures

Primary Outcomes (1)

• Intrauterine adhesion rate

  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

Study Arms (2)

Experimental group

EXPERIMENTAL

Uterine stent placement in the uterine cavity after hysteroscopic intrauterine adhesion separation surgery

Device: Uterine stent group

Control group

EXPERIMENTAL

Uterine cavity insertion ring + balloon + sodium hyaluronate gel

Device: Uterine ring + balloon + sodium hyaluronate gel

Interventions

Uterine stent group DEVICE

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 group

Uterine ring + balloon + sodium hyaluronate gel DEVICE

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.

Control group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Hunan Haokang Medical Technology Co., Ltd.: collaborator
• Beijing Tiantan Hospital: collaborator
• The First Affiliated Hospital of Hunan University of Traditional Chinese Medicine: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Central Study Contacts

Dabao MD

CONTACT

13017386201; forxudabao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 11, 2026
• First Posted: May 28, 2026
• Study Start: January 1, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2031
• Last Updated: May 28, 2026

Record last verified: 2025-05

Locations

CN (1)