FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 7,000
- 试验地点
- 2
- 主要终点
- Sperm concentration in males
研究概览
简要总结
The goal of this observational study is to learn how gonadotoxic treatments (chemotherapies, radiotherapies or immunotherapies) affect the fertility status of participants with cancer.
The main questions it aims to answer are:
- in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve);
- in males, if cancer therapies reduce sperm concentration (sperm quality).
详细描述
This is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in Switzerland belonging to the Swiss network "FertiSAVE" as well as in fertility centers in Germany and Austria belonging to the German-Swiss-Austrian network "FertiPROTEKT" and further international centers who are interested to participate. Both networks include in total around 200 centers.
The data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the REDcap study registry. Patients will be coded by the center to be able to follow them up. Each center will only have access to its own registry data set. Access to the total data set is only permitted for the principal investigator and the specific sub-investigators.
Data collection before the start of gonadotoxic treatment will be performed for 5 years.
Data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 50 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with cancer or with benign reasons undergoing chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immune therapy;
- •Willing to participate;
- •Austria: 14-50 years old (adolescents and adults), Germany: 18-50 years old, Switzerland: 14-50 years old (adolescents and adults);
- •Serum hormone analysis before gonadotoxic therapy (females) or serum hormone analysis and sperm analysis before gonadotoxic therapy (males).
排除标准
- •Missing consent;
- •Language barrier.
结局指标
主要结局
Sperm concentration in males
时间窗: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
Anti-Müllerian hormone (AMH) concentration in females
时间窗: Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
Anti-Müllerian hormone (AMH) concentration in females
时间窗: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
Anti-Müllerian hormone (AMH) concentration in females
时间窗: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
Sperm concentration in males
时间窗: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
Sperm concentration in males
时间窗: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
次要结局
- Number of pregnancies and children born with the help of fertility preservation measures(12-15 months, 5 years and 10 years after the end of gonadotoxic treatment)
- Fertility preservation measures performed(Before the start of gonadotoxic treatment)
- Satisfaction with the decision to have undergone fertility preservation measures or not(12-15 months after the end of gonadotoxic treatment)
- Satisfaction with the fertility preservation counselling before the gonadotoxic treatment(12-15 months after the end of gonadotoxic treatment)
- Number of spontaneous pregnancies and children born(12-15 months, 5 years and 10 years after the end of gonadotoxic treatment)
- Quality of life assessment(12-15 months, 5 years and 10 years after the end of gonadotoxic treatment)
研究者
Michael von Wolff
Prof. Dr. med. Michael von Wolff
Universitätsklinik fur Frauenheilkunde, Inselspital Bern