Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection
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|ClinicalTrials.gov Identifier: NCT02414295|
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
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.
Approximately 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.
Klinefelter syndrome is common in infertile men with oligospermia or azoospermia (5 to 10 percent).
Infertility 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.
Mesenchymal stem cell injection in testicular tubules and intra testicular artery using surgical microscope.
The period for follow up last from three months to twelve months including semen analysis to detect sperm and hormonal profile .
|Condition or disease||Intervention/treatment||Phase|
|Klinefelter Syndrome Azoospermia||Drug: Mesenchymal stem cell injection||Not Applicable|
The problem started with this kind of patinets when underwent multiple TESE without sperm.
The investigators try to inject KS patients with mesenchymal stem cells to stimulate testicular tissue for production of sperms.
before injection the investigators measure:( FSH, LH, Testosterone, Prolactin, Inhibin B, Karyotyping, Azoospermic Factor, Testicular size by ultrasound).
Three to twelf months after stem cell injection the investigators reevaluate patients by the same measure to demoenstarte any changes.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Official Title:||Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||August 2014|
Experimental: Mesenchymal stem cell injection
Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery
Drug: Mesenchymal stem cell injection
Aspirated bone marrow then separation for Mesenchymal stem cell
- Sperm detection [ Time Frame: 12 months ]Semen Analysis
- Hormonal profile [ Time Frame: 12 months ]Inhibine B, FSH, LH
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414295
|Man Clinic for Andrology and male infertility|
|Principal Investigator:||Khaled A Gadalla, MD||Alazhar University|