Ignite Creation Date:
2025-12-26 @ 1:16 PM
Ignite Modification Date:
2025-12-31 @ 11:06 AM
Study NCT ID:
NCT05997706
Status:
UNKNOWN
Last Update Posted:
2023-08-18
First Post:
2019-06-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Unraveling the Klinefelter's Disease Physiopathology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007713', 'term': 'Klinefelter Syndrome'}, {'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D058533', 'term': 'Sex Chromosome Disorders of Sex Development'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D025064', 'term': 'Sex Chromosome Disorders'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007006', 'term': 'Hypogonadism'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-11', 'studyFirstSubmitDate': '2019-06-27', 'studyFirstSubmitQcDate': '2023-08-11', 'lastUpdatePostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Klinefelter's infertility physiopathology", 'timeFrame': 'Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.', 'description': 'Testicular biopsies will be digested using two steps enzymatic protocol. Cell suspensions will be in vitro cultured during 2 months. The following analyses will be performed: cells counts, cells characterisation by immunofluorescence and RTqPCR specific for the cell type, cells karyotypes.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Klinefelter Syndrome', 'fertility preservation, male'], 'conditions': ['Klinefelter Syndrome', 'Infertility, Male']}, 'referencesModule': {'references': [{'pmid': '39237101', 'type': 'DERIVED', 'citation': 'Giudice MG, Kanbar M, Poels J, Duquenne A, Wyns C. Long-term culture of human Sertoli cells from adult Klinefelter patients as a first step to develop new tools for unravelling the testicular physiopathology. Hum Reprod. 2024 Nov 1;39(11):2400-2410. doi: 10.1093/humrep/deae201.'}]}, 'descriptionModule': {'briefSummary': 'Organoid Model to unravel Klinefelter Syndrome infertility\n\nKlinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The investigators will isolate and expand spermatogonial cells from KS patients, then using an organoid model investigators will compare the behavior of these Spermatogonia from KS patients when interacting with four combinations of somatic cell types incorporated in the Extra Cellular Matrix hydrogel.', 'detailedDescription': 'Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction) for azoospermia.\n\nOne extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells isolation and culture.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '5 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Klinefelter\n\nExclusion Criteria:\n\n* Mosaicism'}, 'identificationModule': {'nctId': 'NCT05997706', 'acronym': 'KLINEFELTER', 'briefTitle': "Unraveling the Klinefelter's Disease Physiopathology", 'organization': {'class': 'OTHER', 'fullName': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain'}, 'officialTitle': "Unraveling the Klinefelter's Disease Physiopathology by Organoid Model", 'orgStudyIdInfo': {'id': '2018/27AVR/196'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infertile patients', 'description': 'Infertile patients going to surgery for fertility preservation or infertility treatment at University Clinic Saint-Luc Brussels', 'interventionNames': ['Procedure: Testicular biopsy']}], 'interventions': [{'name': 'Testicular biopsy', 'type': 'PROCEDURE', 'description': 'Testicular biopsy is a clinical procedure for extraction of testicular tissue', 'armGroupLabels': ['Infertile patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1200', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Christine Wyns, MD,PhD', 'role': 'CONTACT'}, {'name': 'Christine Wyns, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Cliniques Universitaires St Luc', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Christine Wyns, MD, PhD', 'role': 'CONTACT', 'email': 'christine.wyns@uclouvain.be', 'phone': '+3227649501'}, {'name': 'Maria Grazia Giudice, MD', 'role': 'CONTACT', 'email': 'maria.giudice@uclouvain.be', 'phone': '+32485256903'}], 'overallOfficials': [{'name': 'Christine Wyns, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cliniques Universitaires St Luc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cliniques universitaires Saint-Luc- Université Catholique de Louvain', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}