Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

Klinefelter Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02414295
• Other study ID #: 6714
• Status: Completed
• Phase: N/A
• First received: August 21, 2014
• Last updated: April 9, 2015
• Start date: August 2013
• Est. completion date: August 2014

Study information

• Verified date: April 2015
• Source: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

• Kleinfelter syndrome

• Azoospermia

• Negative TESE

Exclusion Criteria:

• Absent Testes

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Azoospermia
• Klinefelter Syndrome
• Syndrome

Intervention

Drug:
• Mesenchymal stem cell injection
Aspirated bone marrow then separation for Mesenchymal stem cell

Locations

Country	Name	City	State
Egypt	Man Clinic for Andrology and male infertility	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm detection	Semen Analysis	12 months	Yes
Secondary	Hormonal profile	Inhibine B, FSH, LH	12 months	Yes