Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

NCT02414295 | Completed

• 1 other identifier: 6714
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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 .

Conditions

Klinefelter Syndrome; Azoospermia

Keywords

Stem cell; Kleinfelter syndrome; Azoospermia; Sterility; Infertility

Outcome Measures

Primary Outcomes (1)

• Sperm detection

  Semen Analysis

  12 months

Secondary Outcomes (1)

• Hormonal profile

  12 months

Study Arms (1)

Mesenchymal stem cell injection

EXPERIMENTAL

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

Drug: Mesenchymal stem cell injection

Interventions

Mesenchymal stem cell injection DRUG

Aspirated bone marrow then separation for Mesenchymal stem cell

Mesenchymal stem cell injection

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Kleinfelter syndrome
• Azoospermia
• Negative TESE

You may not qualify if:

• Absent Testes

Sponsors & Collaborators

• Man Clinic for Andrology, Male Infertility and Sexual Dysfunction: lead

Study Sites (1)

Man Clinic for Andrology and male infertility

Cairo, Egypt

Location

MeSH Terms

Conditions

Klinefelter Syndrome; Azoospermia; Infertility

Condition Hierarchy (Ancestors)

Sex Chromosome Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Sex Chromosome Disorders; Chromosome Disorders; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Gonadal Disorders; Endocrine System Diseases; Hypogonadism; Infertility, Male; Genital Diseases, Male; Genital Diseases

Study Officials

• Khaled A Gadalla, MD

  Al-Azhar University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2014
• First Posted: April 10, 2015
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: April 10, 2015

Record last verified: 2015-04

Locations

EG (1)