Clinical trial NCT02414295: Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection
Official title: Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Klinefelter Syndrome
Azoospermia
Keywords: Stem cell
Kleinfelter syndrome
Azoospermia
Sterility
Infertility
Lead sponsor: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 1
Sex: MALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Kleinfelter syndrome
* Azoospermia
* Negative TESE

Exclusion Criteria:

* Absent Testes

Primary outcomes:
measure: Sperm detection
timeFrame: 12 months
Secondary outcomes:
measure: Hormonal profile
timeFrame: 12 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Man Clinic for Andrology and male infertility
Study officials:
affiliation: Al-Azhar University
name: Khaled A Gadalla, MD
role: PRINCIPAL_INVESTIGATOR
References: