Investigating the Association Between Diagnostic and Therapeutic Management Models and Prognosis of Intrauterine Adhesions Based on a Large-Scale Prospective Cohort Study

NCT07421908 | Recruiting

• 1 other identifier: xy3-IUA-Xu
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

This research plan aims to explore a new diagnosis and treatment management model for intrauterine adhesions and verify its efficacy and feasibility through a multicenter real-world study. Intrauterine adhesions are a common gynecological disease that may affect women's fertility. The study will focus on several key issues:

1. 1.How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions;
2. 2.The effect of new diagnostic and treatment technologies (such as cold knife plowing technology and patented intrauterine stents) in preventing the recurrence of intrauterine adhesions
3. 3.The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy;
4. 4.How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine.
5. 5.Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis;
6. 6.Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research;
7. 7.Evaluate the efficacy of the new model through real-world research, and compare the clinical efficacy of the new diagnosis and treatment model with the traditional diagnosis and treatment model;
8. 8.Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application.

Conditions

Intrauterine Adhesion

Keywords

Hysteroscopy; ploughing technique; cold scissors; Gland density; multi-center study

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Pregnancy Outcome within 2 Years of Postoperative Pregnancy Preparation Following Intrauterine Adhesions Surgery

  Based on the constructed IUA integrated traditional Chinese and Western medicine cohort data, data standardization processing was carried out to establish a multi-dimensional candidate variable dataset that may be related to infertility after IUA surgery. It includes multi-dimensional diagnosis and treatment data of both traditional Chinese and Western medicine, such as age, lifestyle and behavioral patterns, family history, laboratory tests, surgical conditions, male semen and sexual life conditions, combined variables of three-dimensional ultrasound image features and combined variables of TCM syndrome elements. Meanwhile, the follow-up results of the corresponding population were sorted out, that is, the pregnancy outcome within 2 years of postoperative pregnancy preparation.

  From the start of postoperative pregnancy preparation up to 2 years

Study Arms (1)

A new model of full-course management and diagnosis and treatment for IUA

EXPERIMENTAL

Procedure: Transcervical resection of adhesion; Procedure: Uterine cavity stent; Drug: Traditional Chinese medicine for tonifying the kidney

Interventions

Transcervical resection of adhesion PROCEDURE

During the operation, an integrated hysteroscopic "immediate diagnosis and immediate treatment" cold knife plowing type adhesion separation surgery was adopted

A new model of full-course management and diagnosis and treatment for IUA

Uterine cavity stent PROCEDURE

Made of medical-grade silicone rubber, it is non-irritating to human tissues, has no toxic side effects, is non-carcinogenic, has good biocompatibility, corrosion resistance, will not swell, soften or deteriorate due to water absorption, is easy to process and manufacture, convenient to use, and has good thermal stability. The uterine stent is mainly composed of the reinforcing ribs of the uterine ring, the membrane, the tail-shaped structure and the placement device. The placement device is composed of the placement sleeve, the positioning block and the push rod. It is made of medical silicone rubber. The uterine ring reinforcing ribs are elastic, and their shape and size are adapted to the periphery of the uterine wall. The lower end of the reinforcing ribs of the uterine ring is equipped with three drainage channels, which is more conducive to the drainage of uterine cavity effusion and reduces the probability of intrauterine infection caused by poor uterine cavity drainage.

A new model of full-course management and diagnosis and treatment for IUA

Traditional Chinese medicine for tonifying the kidney DRUG

Traditional Chinese medicines for tonifying the kidney can promote blood circulation in the internal reproductive organs, significantly increase blood supply to the uterus, improve the receptivity of the endometrium, enhance the affinity of estrogen receptors in target tissues, promote endometrial proliferation, and improve secretory function

A new model of full-course management and diagnosis and treatment for IUA

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-central units of this project: aged 18-45 years old; The collection began after the ethical review was passed. A total of 5,000 cases were collected, and 2,000 cases were collected in this center.

You may not qualify if:

• Abnormal ovarian function, male infertility, inability to cooperate with diagnosis and treatment and follow-up visits

Sponsors & Collaborators

• The Third Xiangya Hospital of Central South University: lead
• Changsha Jiangwan Maternity Hospital: collaborator
• Maternity and Child Health Hospital of Changsha: collaborator

Study Sites (1)

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Interventions

Medicine, Chinese Traditional

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Medicine, East Asian Traditional; Medicine, Traditional; Complementary Therapies; Therapeutics

Central Study Contacts

Dabao Xu

CONTACT

+86 13017386201; forxudabao@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: February 19, 2026
• Study Start: March 1, 2025
• Primary Completion (Estimated): March 1, 2030
• Study Completion (Estimated): March 1, 2035
• Last Updated: February 19, 2026

Record last verified: 2026-02

Locations

CN (1)