Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-03-25 @ 3:20 PM
Study NCT ID:
NCT02414295
Status:
COMPLETED
Last Update Posted:
2015-04-10
First Post:
2014-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007713', 'term': 'Klinefelter Syndrome'}, {'id': 'D053713', 'term': 'Azoospermia'}, {'id': 'D007246', 'term': 'Infertility'}], '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': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2014-08-21', 'studyFirstSubmitQcDate': '2015-04-09', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm detection', 'timeFrame': '12 months', 'description': 'Semen Analysis'}], 'secondaryOutcomes': [{'measure': 'Hormonal profile', 'timeFrame': '12 months', 'description': 'Inhibine B, FSH, LH'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stem cell', 'Kleinfelter syndrome', 'Azoospermia', 'Sterility', 'Infertility'], 'conditions': ['Klinefelter Syndrome', 'Azoospermia']}, 'descriptionModule': {'briefSummary': 'Klinefelter syndrome KS is caused by an additional X chromosome in males (47,XXY). Clinical findings are nonspecific during childhood; thus, the diagnosis commonly is made during adolescence or adulthood in males who have small testes with hypergonadotropic hypogonadism and gynecomastia. Virtually all men with Klinefelter syndrome are infertile.\n\nApproximately one in 1,000 boys is born with an additional X chromosome-47,XXY, the karyotype that causes Klinefelter syndrome. This karyotype is detected at or before birth in 10 percent of affected boys, and it is found during adulthood in 25 percent of affected men. Almost all men with a 47,XXY karyotype will be infertile; Klinefelter syndrome accounts for 3 percent of male infertility.\n\nKlinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent).\n\nInfertility in men with Klinefelter syndrome is caused by a precipitous drop in sperm count. If sperm are present, cryopreservation is useful for future family planning with intracytoplasmic sperm injection, and if not, testicular sperm extraction may be pursued. Although there have been multiple reports of successful fertilization by men with Klinefelter syndrome.\n\nMesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope.\n\nThe period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .', 'detailedDescription': 'The problem started with this kind of patinets when underwent multiple TESE without sperm.\n\nThe investigators try to inject KS patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms.\n\nbefore injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B, Karyotyping, Azoospermic Factor, Testicular size by ultrasound).\n\nThree to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Kleinfelter syndrome\n* Azoospermia\n* Negative TESE\n\nExclusion Criteria:\n\n* Absent Testes'}, 'identificationModule': {'nctId': 'NCT02414295', 'briefTitle': 'Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection', 'organization': {'class': 'OTHER', 'fullName': 'Man Clinic for Andrology, Male Infertility and Sexual Dysfunction'}, 'officialTitle': 'Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection', 'orgStudyIdInfo': {'id': '6714'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mesenchymal stem cell injection', 'description': 'Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery', 'interventionNames': ['Drug: Mesenchymal stem cell injection']}], 'interventions': [{'name': 'Mesenchymal stem cell injection', 'type': 'DRUG', 'description': 'Aspirated bone marrow then separation for Mesenchymal stem cell', 'armGroupLabels': ['Mesenchymal stem cell injection']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Man Clinic for Andrology and male infertility', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Khaled A Gadalla, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Al-Azhar University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Man Clinic for Andrology, Male Infertility and Sexual Dysfunction', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}