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临床试验/NCT02414295
NCT02414295已完成不适用

Management of Azoospermic Patients With Kleinfelter Syndrome Patients With Mesenchymal Stem Cell Injection

Man Clinic for Andrology, Male Infertility and Sexual Dysfunction1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2013年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1
试验地点
1
主要终点
Sperm detection

研究概览

简要总结

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 .

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Kleinfelter syndrome
  • Azoospermia
  • Negative TESE

排除标准

  • Absent Testes

研究组 & 干预措施

Mesenchymal stem cell injection

Experimental

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

干预措施: Mesenchymal stem cell injection (Drug)

结局指标

主要结局

Sperm detection

时间窗: 12 months

Semen Analysis

次要结局

  • Hormonal profile(12 months)

研究者

发起方
Man Clinic for Andrology, Male Infertility and Sexual Dysfunction
申办方类型
Other
责任方
Sponsor

研究点 (1)

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