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Completed

NCT Number: NCT05521932

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Women's Hospital

Hangzhou, Zhejiang, 310000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • clinical diagnosis of IUA
  • undergoing hysteroscopic surgery for treatment

Exclusion criteria

·receiving sex hormone therapy in the three months before surgery

Treatment and study plan

endometrium collected

Other

endometrium tissue collected following adhesiolysis surgery

Primary outcomes

  1. IUA organoid formation efficiency

    Time frame: 2 years

    Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated:

    • the formation efficiency of organoid
  2. IUA organoid proliferative rate

    Time frame: 2 years

    Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated:

    • the proliferative rate of organoid

Secondary outcomes

  1. IUA organoid identification

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Women's Hospital School Of Medicine Zhejiang University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Aug 30, 2022
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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