Ignite Creation Date:
2025-12-24 @ 10:02 PM
Ignite Modification Date:
2026-02-26 @ 11:04 AM
Study NCT ID:
NCT01750632
Status:
COMPLETED
Last Update Posted:
2016-10-04
First Post:
2012-12-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Subcapsular Orchiectomy in Men With Klinefelter Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007713', 'term': 'Klinefelter Syndrome'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009919', 'term': 'Orchiectomy'}], 'ancestors': [{'id': 'D002369', 'term': 'Castration'}, {'id': 'D013507', 'term': 'Endocrine Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}, {'id': 'D013521', 'term': 'Urologic Surgical Procedures, Male'}, {'id': 'D013520', 'term': 'Urologic Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-10-03', 'studyFirstSubmitDate': '2012-12-08', 'studyFirstSubmitQcDate': '2012-12-13', 'lastUpdatePostDateStruct': {'date': '2016-10-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Predictive value of FSH and other hormones for the presence of testicular sperm', 'timeFrame': 'Between 1 and 6 months'}], 'primaryOutcomes': [{'measure': 'Presence of testicular sperm', 'timeFrame': 'Between 1 and 6 months'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate after ICSI with retrieved testicular sperm', 'timeFrame': 'participants will be followed for the duration of fertility treatment, an expected average of 6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Klinefelter Syndrome']}, 'referencesModule': {'references': [{'pmid': '26254174', 'type': 'RESULT', 'citation': 'Fedder J, Gravholt CH, Kristensen SG, Marcussen N, Engvad B, Milton AM, Andersen CY. Testicular Sperm Sampling by Subcapsular Orchiectomy in Klinefelter Patients: A New Simplified Treatment Approach. Urology. 2015 Oct;86(4):744-50. doi: 10.1016/j.urology.2015.06.044. Epub 2015 Aug 4.'}]}, 'descriptionModule': {'briefSummary': 'Men with Klinefelter syndrome undergo unilateral subcapsular ochiectomy, and the removed testicular tissue is examined for presence of sperm and cryopreserved in small pieces for fertility treatment and scientific purposes. Prior to operation blood samples are frozen in a biobank.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '40 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Klinefelter\n* 15-40 years of age\n\nExclusion Criteria:\n\n* inability to understand the study'}, 'identificationModule': {'nctId': 'NCT01750632', 'briefTitle': 'Subcapsular Orchiectomy in Men With Klinefelter Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'orgStudyIdInfo': {'id': 'Lab.Reprod.Biol.-Horsens-02'}, 'secondaryIdInfos': [{'id': 'M-20100041'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Orchiectomy', 'description': 'The patients undergo subcapsular orchiectomy', 'interventionNames': ['Procedure: Orchiectomy']}], 'interventions': [{'name': 'Orchiectomy', 'type': 'PROCEDURE', 'description': 'The patients undergo subcapsular orchiectomy with basic surgical instruments. The patients are given local analgesia and sometimes universal anesthesia.', 'armGroupLabels': ['Orchiectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Fertility Clinic, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Copenhagen', 'class': 'OTHER'}, {'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant, Ph.D.', 'investigatorFullName': 'Jens Fedder', 'investigatorAffiliation': 'Odense University Hospital'}}}}