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

NCT ID: NCT05521932

Last Updated: 2025-03-27

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 6 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-09-20
• Study Completion Date: 2024-12-31

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.

Conditions

Asherman Syndrome

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

IUA organoid

Organoids were generated from endometrial specimens remaining from pathological testing following adhesiolysis surgery.

endometrium collected

Intervention Type: OTHER

endometrium tissue collected following adhesiolysis surgery

Interventions

endometrium collected

endometrium tissue collected following adhesiolysis surgery

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• clinical diagnosis of IUA
• undergoing hysteroscopic surgery for treatment

Exclusion Criteria

·receiving sex hormone therapy in the three months before surgery

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Women's Hospital School Of Medicine Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ruijin Wu, M.D.

Role: STUDY_CHAIR

Women's Hospital, College of Medicine Zhejiang University

Locations

Women's Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

Ruijin Wu

Identifier Type: -

Identifier Source: org_study_id