FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cancer
- Sponsor
- Michael von Wolff
- Enrollment
- 7000
- Locations
- 1
- Primary Endpoint
- Sperm concentration in males
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
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).
Detailed Description
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).
Investigators
Michael von Wolff
Prof. Dr. med. Michael von Wolff
Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Eligibility Criteria
Inclusion Criteria
- •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).
Exclusion Criteria
- •Missing consent;
- •Language barrier.
Outcomes
Primary Outcomes
Sperm concentration in males
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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)