Clinical trial NCT05521932: Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair
Official title: Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asherman Syndrome
Keywords: organoid
Asherman Syndrome
intrauterine adhesion
Lead sponsor: Women's Hospital School Of Medicine Zhejiang University
Sponsor class: OTHER
First posted: 2022-08-30
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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

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.

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

Primary outcomes:
measure: IUA organoid formation efficiency
timeFrame: 2 years
measure: IUA organoid proliferative rate
timeFrame: 2 years
Secondary outcomes:
measure: IUA organoid identification
timeFrame: 2 years
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Women's Hospital
state: Zhejiang
Study officials:
affiliation: Women's Hospital, College of Medicine Zhejiang University
name: Ruijin Wu, M.D.
role: STUDY_CHAIR
References: