Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

Not Applicable

Completed

• Conditions: Azoospermia; Klinefelter Syndrome
• Interventions: Drug: Mesenchymal stem cell injection

• Registration Number: NCT02414295
• Lead Sponsor: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

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 .

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.

Study Timeline

• Study Start: 2013-08
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Study First Submitted: 2014-08-21
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-09
• Last Update Submitted: 2015-04-09
• Study First Posted: 2015-04-10
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 1

Inclusion Criteria

• Kleinfelter syndrome
• Azoospermia
• Negative TESE

Exclusion Criteria

• Absent Testes

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mesenchymal stem cell injection	Mesenchymal stem cell injection	Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery

Primary Outcome Measures

Name	Time	Method
Sperm detection	12 months	Semen Analysis

Secondary Outcome Measures

Name	Time	Method
Hormonal profile	12 months	Inhibine B, FSH, LH

Trial Locations

Locations (1)

Man Clinic for Andrology and male infertility; 🇪🇬 Cairo, Egypt