Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02414295
Recruitment Status : Completed
First Posted : April 10, 2015
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):
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 .


Condition or disease Intervention/treatment Phase
Klinefelter Syndrome Azoospermia Drug: Mesenchymal stem cell injection Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection
Study Start Date : August 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Mesenchymal stem cell injection
Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery
Drug: Mesenchymal stem cell injection
Aspirated bone marrow then separation for Mesenchymal stem cell




Primary Outcome Measures :
  1. Sperm detection [ Time Frame: 12 months ]
    Semen Analysis


Secondary Outcome Measures :
  1. Hormonal profile [ Time Frame: 12 months ]
    Inhibine B, FSH, LH



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Kleinfelter syndrome
  • Azoospermia
  • Negative TESE

Exclusion Criteria:

  • Absent Testes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02414295


Locations
Layout table for location information
Egypt
Man Clinic for Andrology and male infertility
Cairo, Egypt
Sponsors and Collaborators
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
Investigators
Layout table for investigator information
Principal Investigator: Khaled A Gadalla, MD Alazhar University

Layout table for additonal information
Responsible Party: Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
ClinicalTrials.gov Identifier: NCT02414295     History of Changes
Other Study ID Numbers: 6714
First Posted: April 10, 2015    Key Record Dates
Last Update Posted: April 10, 2015
Last Verified: April 2015

Keywords provided by Man Clinic for Andrology, Male Infertility and Sexual Dysfunction:
Stem cell
Kleinfelter syndrome
Azoospermia
Sterility
Infertility

Additional relevant MeSH terms:
Layout table for MeSH terms
Syndrome
Azoospermia
Klinefelter Syndrome
Disease
Pathologic Processes
Infertility, Male
Infertility
Genital Diseases, Male
Sex Chromosome Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Sex Chromosome Disorders
Chromosome Disorders
Congenital Abnormalities
Genetic Diseases, Inborn
Gonadal Disorders
Endocrine System Diseases
Hypogonadism