Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-12 @ 5:23 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:
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Organization:
Study Overview
Official Title:
Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 .
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:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: