FertiTOX® A platform for gonadotoxicity of cancer therapies
Cancer therapies can harm the gonads. In high risk situations fertility preservation treatments such as freezing of oocytes, ovarian tissue, sperm and testicular tissue might be required. However, data about the risks of specific cancer therapies and the necessity to perform fertility preservation treatments is very limited.
Therefore the platform FertiTOX® will be set up to present systematically reviewed published data on the gonadotoxicity as well as prospectively collected data, collected in 3 countries by around 60 centres in Germany, Switzerland and Austria, having started data collection in 2024. These centres mainly belong to the network FertiPROTEKT®. The platform will be set up in 2026.
Prof. Michael von Wolff
Prof. Ariane Germeyer
PD Dr. Bettina Böttcher
Irene Marcu, PhD
Dr. Susanna Weidlinger
Dr. Janna Pape
Dr. Isotta Magaton
Prof. Nicole Sänger
PD Dr. Verena Nordhoff
Marie Roumet, PhD
Study protocol and documents for the study
First, previously published data is systematically analysed regarding the gonadotoxicity of chemo and radiotherapies in cancer patients.
Second, a prospective cohort study is performed to collect the following data in the study registry REDCap: ovarian function is evaluated by analysing AMH, FSH, LH and E2 concentrations and testicular function by analysing sperm parameters and total testosterone, just before and 12-15 months after the end of the gonadotoxic therapy (short term fertility). These fertility parameters, as well as the history of conceptions, will be collected 5 and 10 years after gonadotoxic therapies (long term fertility).
Furthermore, proportion of patients undergoing fertility preserving methods, efficacy and satisfaction with these methods will be analysed.
Third, the data will be merged to create the internet based data platform FertiTOX. The platform will be structured according to the ICD classification of cancer diseases and will be easily accessible using a specific App.
A description of the study has been submitted and will be found in the website menu “Papers published”.
Material such as paper versions of the REDCap study registry can also be downloaded (see PDF files below):
- REDCap registry: Documentation in females before gonadotoxic therapy
- REDCap registry: Documentation in males before gonadotoxic therapy
- REDCap registry: Documentation in females 12-15 months after the end of gonadotoxic therapy
- REDCap registry: Documentation in males 12-15 months after the end of gonadotoxic therapy
The paper versions can be used in the outpatient clinic to collect data to be added to the registry later.
The restrospective data analysis is performed in the fertility centre in Inselspital Bern, Switzerland. Data for the prospective cohort study are collected in 15 centres in Germany, 21 centres in Switzerland and 1 centre in Austria. The complete list of the participating centres can be downloaded here.
Other centres are invited to contribute to the study if the study is accepted by their local ethical committee and if they add their data to the study registry. In case of interest, please contact the coordinator Michael von Wolff.
Several sponsors have provided financial support for 4 years (2023 to 2026).
The project is mainly sponsored by public foundations such as the Swiss cancer league with a grant of CHF 349.000,- (Grant number KLS-5650-08-2022).
A further competitive grant application has been submitted to the German “Deutsche Krebshilfe”.
The project is also financially supported by some companies.
Swiss cancer league
IBSA Institut Biochimique SA
Theramex Switzerland GmbH
Ferring Pharmaceuticals SA
Papers and Abstracts published and submitted
Evaluation of gonadotoxicity of cancer therapies to improve counselling of patients regarding fertility and fertility preservation measures: Protocol for a retrospective systematic data analysis and a prospective cohort study
A systematic review of the gonadotoxicity of osteosarcoma and Ewing´s sarcoma chemotherapies in postpubertal females and males
Systematic review of the gonadotoxicity and risk of infertility of soft tissue sarcoma chemotherapies in pre- and postpubertal females and males
Impact on Fertility Outcomes in Survivors after Hematopoietic Stem Cell Transplantation for Benign and Malignant Hematologic Disorders: A systematic review and meta-analysis
Oncological treatments have limited effects on the fertility prognosis in testicular cancer: A systematic review and meta-analysis
Further abstracts of systematic reviews and/or meta-analyses to be uploaded in 2024
- Breast cancer
- Cerebral cancer
- Hodgkin’s lymphoma
- Rectal/Sigmoid cancer
- Non-Hodgkin's lymphoma
The project has been initiated and is coordinated by Michael von Wolff.
The representative and contact person for Germany is Ariane Germeyer, for Switzerland Michael von Wolff and for Austria Bettina Böttcher.