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

Asherman Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05521932
• Other study ID #: Ruijin Wu
• Status: Recruiting
• Start date: September 20, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: May 2024
• Source: Women's Hospital School Of Medicine Zhejiang University
• Contact: Ruijin Wu, M.D.
• Phone: 0086-0571-87061501
• Email: wurj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of IUA

• undergoing hysteroscopic surgery for treatment

Exclusion Criteria:

·receiving sex hormone therapy in the three months before surgery

Related Conditions & MeSH terms

• Asherman Syndrome

Intervention

Other:
• endometrium collected
endometrium tissue collected following adhesiolysis surgery

Locations

Country	Name	City	State
China	Women's Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Women's Hospital School Of Medicine Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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