Female Fertility Preservation Using Ovarian Tissue Cryopreservation Before Highly Gonadotoxic Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 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 ovarian 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, only the experimental option of ovarian tissue cryopreservation can be proposed to prepubertal girls with a high risk of infertility. For pubertal patient, cryopreservation of mature oocytes after ovarian stimulation can be offered if oncological treatment debut can be delayed. As it is often not possible, ovarian tissue cryopreservation can also be offered.
Primary aims
- To cryopreserve ovarian tissue of pre or peripubertal patient who will be receiving highly gonadotoxic oncological treatment.
Secondary aims
- To create a database in order to record clinical and biological follow-up data
- To pool resources with Fertisave Registry
- To create a research biobank for future research projects
Multicentric study: HUG, CHUV
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
- 2 Months 至 18 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pediatric pre ou peripubertal patient aged 2 months and older
- •Patient presenting high risk of infertility because of gonadotoxic treatments (i.e. high dose of alkylating agents, ovarian irradiation, total body irradiation)
- •Multidisciplinary team consensus in favour to proposition to cryopreserve ovarian tissue.
排除标准
- •Patient under the age of 2 months
- •Refusal of the patient and/or her parents
- •Treatments that are not highly gonadotoxic
研究组 & 干预措施
ovarian tissue cryopreservation
干预措施: ovarian tissue biopsy (Procedure)
结局指标
主要结局
Number of pediatric cancer patient who will undergo ovarian tissue cryopreservation for fertility preservation
时间窗: 0-20 years
次要结局
- Incidence of complications related to the ovarian biopsy (safety)(0-20 years)
- Comparison of biochemical markers(0-20 years)
研究者
Gumy-Pause Fabienne
Principal Investigator
University Hospital, Geneva