Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-05 @ 5:34 PM
Study NCT ID:
NCT05521932
Status:
COMPLETED
Last Update Posted:
2025-03-27
First Post:
2022-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006175', 'term': 'Gynatresia'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'endometrium tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2022-08-19', 'studyFirstSubmitQcDate': '2022-08-26', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'IUA organoid formation efficiency', 'timeFrame': '2 years', 'description': 'Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated:\n\n* the formation efficiency of organoid'}, {'measure': 'IUA organoid proliferative rate', 'timeFrame': '2 years', 'description': 'Establishment IUA organoid from patient-derived endometrium tissue. The following outcome measure would be calculated:\n\n* the proliferative rate of organoid'}], 'secondaryOutcomes': [{'measure': 'IUA organoid identification', 'timeFrame': '2 years', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['organoid', 'Asherman Syndrome', 'intrauterine adhesion'], 'conditions': ['Asherman Syndrome']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nOrganoids 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.\n\nTherefore, investigator proposed to establish a IUA organoids bio-bank for further investigation of pathogenesis of IUA and seek for personalized therapy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients undergoing intrauterine adhesiolysis surgery at the Department of Gynecology of the Women's Hospital, School of Medicine, Zhejiang University", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of IUA\n* undergoing hysteroscopic surgery for treatment\n\nExclusion Criteria:\n\n·receiving sex hormone therapy in the three months before surgery'}, 'identificationModule': {'nctId': 'NCT05521932', 'briefTitle': 'Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'Establishment and Application of Endometrial 3D-organoid in Endometrial Injury Repair', 'orgStudyIdInfo': {'id': 'Ruijin Wu'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IUA organoid', 'description': 'Organoids were generated from endometrial specimens remaining from pathological testing following adhesiolysis surgery.', 'interventionNames': ['Other: endometrium collected']}], 'interventions': [{'name': 'endometrium collected', 'type': 'OTHER', 'description': 'endometrium tissue collected following adhesiolysis surgery', 'armGroupLabels': ['IUA organoid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': "Women's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'overallOfficials': [{'name': 'Ruijin Wu, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': "Women's Hospital, College of Medicine Zhejiang University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}