Unraveling the Klinefelter's Disease Physiopathology by Organoid Model
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Klinefelter's infertility physiopathology
研究概览
简要总结
Organoid Model to unravel Klinefelter Syndrome infertility
Klinefelter Syndrome (KS) is characterized by the presence of an extra chromosome X in male (47,XXY), it is the most frequent genetic cause of azoospermia in adult men. The investigators will isolate and expand spermatogonial cells from KS patients, then using an organoid model investigators will compare the behavior of these Spermatogonia from KS patients when interacting with four combinations of somatic cell types incorporated in the Extra Cellular Matrix hydrogel.
详细描述
Men with Klinefelter Syndrome candidate for TESE or microTESE (testicular sperm extraction) for azoospermia.
One extra testicular biopsy (1-2 mm) will be cryopreserved and used later for the cells isolation and culture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 50 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Klinefelter
排除标准
- •Mosaicism
结局指标
主要结局
Klinefelter's infertility physiopathology
时间窗: Up to 60 days with intermediate time analyses at the 5th and 10 th passage of cultures.
Testicular biopsies will be digested using two steps enzymatic protocol. Cell suspensions will be in vitro cultured during 2 months. The following analyses will be performed: cells counts, cells characterisation by immunofluorescence and RTqPCR specific for the cell type, cells karyotypes.
次要结局
未报告次要终点