Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair

Completed

• Conditions: Asherman Syndrome
• Interventions: Other: endometrium collected

• Registration Number: NCT05521932
• Lead Sponsor: Women's Hospital School Of Medicine Zhejiang University

Brief Summary

Normal endometrial repair occurs without scar formation; however, in some women, these normal repair mechanisms are aberrant, resulting in intrauterine adhesion (IUA) formation. Intrauterine adhesion (IUA) is one of the common causes of secondary infertility, accounting for approximately 8% of disease etiologies while the pathogenesis of IUA remains unclear. Organoids derived from IUA endometrium can be used as excellent models to study IUA due to genetically stable passage and the characteristics of simulating the microenvironment of the uterine cavity.

Detailed Description

Intrauterine adhesion (IUA), also known as Asherman syndrome, is a common gynecological disease, the main clinical manifestations are oligomenorrhea, amenorrhea, recurrent miscarriage and infertility, which seriously endanger the reproductive function of women of childbearing age . Trauma and infection are the most common and important causes of IUA. At present, the incidence of infertility in the population is about 9%-18%. According to the prediction of World Health Organization (WHO), IUA will become the third largest disease after tumor and cardiovascular disease in the future.

Organoids are 3D self-organized structures that could derived from tissue and have a variety types of cell, and mimic the target organ in structure and function. They have the ability to proliferate, differentiate and self-renew. Maintain genetic stability and reproduce some physiological functions. Organoids forms closer intercellular connections and biological communication than 2D cultured cells, and is better used to simulate the occurrence process and physiological and pathological states of organs and tissues.

Therefore, investigator proposed to establish a IUA organoids bio-bank for further investigation of pathogenesis of IUA and seek for personalized therapy.

Study Timeline

• Study First Submitted: 2022-08-19
• Study First Submitted QC: 2022-08-26
• Study First Posted: 2022-08-30
• Study Start: 2022-09-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 6

Inclusion Criteria

• clinical diagnosis of IUA
• undergoing hysteroscopic surgery for treatment

Exclusion Criteria

·receiving sex hormone therapy in the three months before surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IUA organoid	endometrium collected	Organoids were generated from endometrial specimens remaining from pathological testing following adhesiolysis surgery.

Primary Outcome Measures

Name	Time	Method
IUA organoid proliferative rate	2 years	Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated: * the proliferative rate of organoid
IUA organoid formation efficiency	2 years	Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated: * the formation efficiency of organoid

Secondary Outcome Measures

Name	Time	Method
IUA organoid identification	2 years	the IUA organoid identification will assessed by the following method: Identification of cell type and ultrastructure of IUA organoid by pathological staining and electron microscope.

Trial Locations

Locations (1)

Women's Hospital; 🇨🇳 Hangzhou, Zhejiang, China