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Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

Primary Purpose

Klinefelter Syndrome, Azoospermia

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Mesenchymal stem cell injection
Sponsored by
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Klinefelter Syndrome focused on measuring Stem cell, Kleinfelter syndrome, Azoospermia, Sterility, Infertility

Eligibility Criteria

20 Years - 50 Years (Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Kleinfelter syndrome
  • Azoospermia
  • Negative TESE

Exclusion Criteria:

  • Absent Testes

Sites / Locations

  • Man Clinic for Andrology and male infertility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mesenchymal stem cell injection

Arm Description

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

Outcomes

Primary Outcome Measures

Sperm detection
Semen Analysis

Secondary Outcome Measures

Hormonal profile
Inhibine B, FSH, LH

Full Information

First Posted
August 21, 2014
Last Updated
April 9, 2015
Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
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1. Study Identification

Unique Protocol Identification Number
NCT02414295
Brief Title
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

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Klinefelter Syndrome, Azoospermia
Keywords
Stem cell, Kleinfelter syndrome, Azoospermia, Sterility, Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
N/A
Enrollment
1 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal stem cell injection
Arm Type
Experimental
Arm Description
Bone marrow Mesenchymal stem cell injection in the testicular tubules and testicular artery
Intervention Type
Drug
Intervention Name(s)
Mesenchymal stem cell injection
Intervention Description
Aspirated bone marrow then separation for Mesenchymal stem cell
Primary Outcome Measure Information:
Title
Sperm detection
Description
Semen Analysis
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Hormonal profile
Description
Inhibine B, FSH, LH
Time Frame
12 months

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Kleinfelter syndrome Azoospermia Negative TESE Exclusion Criteria: Absent Testes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khaled A Gadalla, MD
Organizational Affiliation
ALAZHAR UNIVERSITY
Official's Role
Principal Investigator
Facility Information:
Facility Name
Man Clinic for Andrology and male infertility
City
Cairo
Country
Egypt

12. IPD Sharing Statement

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Sperm Production in Kleinfelter Syndrome Patients After Mesenchymal Stem Cell Injection

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