Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

Study Overview
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Brief Summary
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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 .

Detailed Description
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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.

Official Title
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Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection

Conditions
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Klinefelter Syndrome, Azoospermia

Intervention / Treatment
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* Drug: Mesenchymal stem cell injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kleinfelter syndrome Azoospermia Negative TESE Exclusion Criteria: Absent Testes

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mesenchymal stem cell injection<br>Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery | Drug: Mesenchymal stem cell injection<br>* Aspirated bone marrow then separation for Mesenchymal stem cell<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm detection | Semen Analysis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hormonal profile | Inhibine B, FSH, LH | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, Kleinfelter syndrome, Azoospermia, Sterility, Infertility