Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

NCT ID: NCT02414295

Last Updated: 2015-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-08-31
• Study Completion Date: 2014-08-31

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.

Conditions

Klinefelter Syndrome; Azoospermia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Mesenchymal stem cell injection

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

Group Type: EXPERIMENTAL

Mesenchymal stem cell injection

Intervention Type: DRUG

Aspirated bone marrow then separation for Mesenchymal stem cell

Interventions

Mesenchymal stem cell injection

Aspirated bone marrow then separation for Mesenchymal stem cell

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Kleinfelter syndrome
• Azoospermia
• Negative TESE

Exclusion Criteria

• Absent Testes

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khaled A Gadalla, MD

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Locations

Man Clinic for Andrology and male infertility

Cairo, , Egypt

Countries

Egypt

Other Identifiers

6714

Identifier Type: -

Identifier Source: org_study_id