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

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ClinicalTrials.gov Identifier: NCT05521932
Recruitment Status : Not yet recruiting
First Posted : August 30, 2022
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Asherman Syndrome 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.

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair
Estimated Study Start Date : September 20, 2022
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 1, 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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.


Biospecimen Retention:   Samples With DNA
endometrium tissue


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
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
Criteria

Inclusion Criteria:

  • clinical diagnosis of IUA
  • undergoing hysteroscopic surgery for treatment

Exclusion Criteria:

·receiving sex hormone therapy in the three months before surgery


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05521932


Contacts
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Contact: Ruijin Wu, M.D. 86-15868847877 wurj@zju.edu.cn
Contact: Bingning Xu, M.D. 86-13757149209 12018521@zju.edu.cn

Sponsors and Collaborators
Women's Hospital School Of Medicine Zhejiang University
Investigators
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Study Chair: Ruijin Wu, M.D. Women's Hospital, College of Medicine Zhejiang University
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Responsible Party: Women's Hospital School Of Medicine Zhejiang University
ClinicalTrials.gov Identifier: NCT05521932    
Other Study ID Numbers: Ruijin Wu
First Posted: August 30, 2022    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Women's Hospital School Of Medicine Zhejiang University:
organoid
Asherman Syndrome
intrauterine adhesion
Additional relevant MeSH terms:
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Gynatresia