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临床试验/NCT01918280
NCT01918280已完成不适用

Fertility Preservation in Cases of Spermatogenesis Failure : Prospective Study for Klinefelter Syndrome With Non-mosaic Karyotype (47, XXY, Homogeneous)

Hospices Civils de Lyon8 个研究点 分布在 1 个国家目标入组 141 人开始时间: 2010年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
141
试验地点
8
主要终点
TEsticular Sperm Extraction (TESE)

研究概览

简要总结

Klinefelter Syndrome (KS) is the most common sex chromosomal abnormalities (1/600 newborn males), and is characterized by a hypergonadism hypogonadism. Until few years ago, mostly non-mosaic KS was considered as a model of a complete male infertility although few KS (4-8%) have an oligospermia. Recent studies in adult with non-mosaic KS reported the possibility of sperm retrieval by testicular biopsy (TESE) in around 50% cases and more than some pregnancies have been obtained after TESE with Intracytoplasmic Sperm Injection (ICSI). Since 1997, more than one hundred births are described.

As some studies shown a decrease of successful sperm retrieval with the increasing of age, we plan to compare the potential of sperm retrieval between two groups "adult" (23-55 years) and "young" after the onset of puberty (15-22 years). The study will be performed by searching spermatozoa on two seminal analyses spaced out 3 months followed by a testicular biopsy if the azoospermia is confirmed on semen analyses.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
15 Years 至 55 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Klinefelter Syndrome with 47,XXY non-mosaic
  • Androgenotherapy stopped since more than 6 months

排除标准

  • Antecedent of Radiotherapy or chemotherapy
  • Psychological trouble
  • Treatment interfering with spermatogenesis
  • Androgenotherapy non stopped

结局指标

主要结局

TEsticular Sperm Extraction (TESE)

时间窗: 15 months

Improvement of sperm retrieval rate by Testicular Sperm extraction (TESE) in the "Young" group compare to "Adult" group.

次要结局

  • Androgenotherapy(15 months)
  • Prognosis factors(15 months)
  • Histopathologist analyses(15 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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