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NCT Number: NCT07421908

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

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. How do three-dimensional ultrasound image features reflect the diagnosis and prognosis of intrauterine adhesions; 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. The efficacy of traditional Chinese medicine prescriptions in promoting endometrial growth and preserving pregnancy; 4. How to construct a postoperative infertility risk prediction model that combines multidimensional risk factors of traditional Chinese and Western medicine.

To achieve these goals, the study will:

1. Establish four-dimensional ultrasound diagnostic evaluation standards to improve the accuracy of diagnosis; 2. Build a large database and data cohort, standardize the diagnosis and treatment standards, and provide solid data support for the research; 3. 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; 4. Construct and verify the postoperative infertility risk prediction model to provide clinicians with a visual display of risk prediction for clinical application.

This study is expected to provide a scientific basis for improving the treatment effect of intrauterine adhesions and reducing the infertility rate, and promote the standardization and standardization of the diagnosis and treatment model of combining traditional Chinese and Western medicine, bringing good news to more patients with intrauterine adhesions.

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Key information

Conditions

Intrauterine Adhesion Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynatresia Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

The Third Xiangya Hospital of Central South University

Changsha, Hunan, 410013, China

Location status: Recruiting

Location contact

Dabao Xu

CONTACT

[email protected]

+86 13017386201

About this study

Research purpose: This project intends to explore the efficacy of the new IUA diagnosis and treatment model through multi-center real-world research and prove that it is a high-quality medical service model, laying the foundation for its future promotion.

Experimental design: Based on previous research, our team proposed a "new model for the management and treatment of IUA throughout the entire course of disease": preoperative four-dimensional color ultrasound diagnosis and evaluation, intraoperative use of integrated hysteroscopy "immediate diagnosis and treatment" cold knife plowing adhesion separation, postoperative application of patented uterine cavity stent to prevent re-adhesion, postoperative use of famous doctors and famous prescriptions to promote endometrial repair, postoperative use of four-dimensional color ultrasound evaluation follow-up instead of multiple hysteroscopy, combined with intraoperative hysteroscopy endometrial gland opening AI counting gland density, multimodal data fusion prediction and evaluation of pregnancy prognosis after IUA treatment.

Experimental process: Prospective, observational real event study Inclusion criteria: Patients with intrauterine adhesions diagnosed and treated in our hospital and the sub-center units of this project: age 18-45 years old; collection began after the ethical review, a total of 5,000 cases were collected, and 2,000 cases were collected in this center.

Exclusion criteria

abnormal ovarian function, male infertility, and those who cannot cooperate with diagnosis, treatment and follow-up

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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

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.

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

Primary outcomes

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

    Time frame: From the start of postoperative pregnancy preparation up to 2 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dabao Xu

CONTACT

[email protected]

+86 13017386201

Sponsors and collaborators

Lead sponsor

The Third Xiangya Hospital of Central South University

Other

Collaborators

  • Changsha Jiangwan Maternity Hospital
  • Maternity and Child Health Hospital of Changsha

Registry information

Important dates

Study start
2025
Primary completion
2030
Study completion
2035
First posted
Feb 19, 2026
Registry last updated
Feb 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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