Male Fertility Preservation Using Cryopreservation of Testicular Tissue Before Highly Gonadotoxic Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
研究概览
简要总结
Background:
Due to the remarkable improvement in treatments these last decades, long term survival can be expected in more than 80% of childhood cancer patients. Unfortunately, cancer treatments can be harmful to the gonads and can affect reproductive and endocrine functions. While loss of fertility is a major concern for most patients, sperm cryopreservation should be offered to all pubertal male patients. For prepubertal boys, only the experimental option of testicular biopsy in order to cryopreserve testicular stem cells can be proposed.
Primary aims
- To cryopreserve testicular tissue of prepubertal patient receiving highly gonadotoxic oncological treatment.
Secondary aims
- To cryopreserve testicular tissue after failure of sperm cryopreservation in pubertal patient with high risk of infertility
- To create a database in order to record clinical and biological follow-up data
- To create a research biobank for future research projects
Multicentric study: HUG, CHUV, UKBB
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 3 Months 至 18 Years（Child, Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Prepubertal patients aged 3 months and older
- •Peri and pubertal patients after failure of sperm cryopreservation
- •Patients presenting high risk of infertility because of gonadotoxic treatments (i.e high dose of alkylating agents, testicular irradiation, total body irradiation).
- •Multidisciplinary team consensus in favour of proposition to cryopreserve testicular tissue
排除标准
- •Patients under the age of 3 months
- •Refusal of the patient and/or his parents
- •Treatments that are not highly gonadotoxic
研究组 & 干预措施
testicular tissue cryopreservation
干预措施: testicular tissue biopsy (Procedure)
结局指标
主要结局
Number of pediatric cancer patient who will undergo testicular tissue cryopreservation for fertility preservation
时间窗: 0-20 years
次要结局
- Incidence of complications related to the testicular biopsy (safety)(0-20 years)
- Comparison of biochemical markers(0-20 years)
研究者
Gumy-Pause Fabienne
Principal Investigator
University Hospital, Geneva