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

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.

Study Overview

• Status: Completed
• Conditions: Asherman Syndrome
• Intervention / Treatment: Other: endometrium collected

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 Type: Observational
• Enrollment (Actual): 6

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing intrauterine adhesiolysis surgery at the Department of Gynecology of the Women's Hospital, School of Medicine, Zhejiang University

Description

Inclusion Criteria:

• clinical diagnosis of IUA
• undergoing hysteroscopic surgery for treatment

Exclusion Criteria:

·receiving sex hormone therapy in the three months before surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
IUA organoid; Organoids were generated from endometrial specimens remaining from pathological testing following adhesiolysis surgery.	Other: endometrium collected; endometrium tissue collected following adhesiolysis surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IUA organoid formation efficiency	Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated: the formation efficiency of organoid	2 years
IUA organoid proliferative rate	Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated: the proliferative rate of organoid	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IUA organoid identification	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.	2 years

Collaborators and Investigators

• Sponsor: Women's Hospital School Of Medicine Zhejiang University
• Investigators: Study Chair: Ruijin Wu, M.D., Women's Hospital, College of Medicine Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): September 20, 2022
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: August 19, 2022
• First Submitted That Met QC Criteria: August 26, 2022
• First Posted (Actual): August 30, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2025
• Last Update Submitted That Met QC Criteria: March 26, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Asherman Syndrome; organoid; intrauterine adhesion
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Gynatresia
• Other Study ID Numbers: Ruijin Wu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No