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

NCT05521932 | Completed

• 1 other identifier: Ruijin Wu
• Study Type: observational
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Asherman Syndrome

Keywords

organoid; Asherman Syndrome; intrauterine adhesion

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• IUA organoid identification

  2 years

Study Arms (1)

IUA organoid

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

Other: endometrium collected

Interventions

endometrium collected OTHER

endometrium tissue collected following adhesiolysis surgery

IUA organoid

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

You may qualify if:

• clinical diagnosis of IUA
• undergoing hysteroscopic surgery for treatment

You may not qualify if:

• ·receiving sex hormone therapy in the three months before surgery

Sponsors & Collaborators

• Women's Hospital School Of Medicine Zhejiang University: lead

Study Sites (1)

Women's Hospital

Hangzhou, Zhejiang, 310000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

endometrium tissue

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Ruijin Wu, M.D.

  Women's Hospital, College of Medicine Zhejiang University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 30, 2022
• Study Start: September 20, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2025

Record last verified: 2025-03

Locations

CN (1)