JMIR Publications

ABSTRACT

Cytotoxic treatments such as chemo- and radiotherapy and immune therapies are required in cancer diseases. These therapies have the potential to cure patients, but may also have an impact on gonadal function and therefore on fertility. Consequently, fertility preservation treatments such as freezing of oocytes, ovarian tissue, sperm and testicular tissue might be required. However, as detailed data about the necessity to perform fertility preservation treatment is very limited the following study was set up to fill this gap of data. Primary objective of the study is to analyse the impact of cancer therapies and chemotherapies on the ovarian reserve (AMH concentration) and on sperm quality (sperm count and concentration). Secondary objectives are to analyse the impact of cancer therapies and chemotherapies on other fertility parameters and to analyse the probability of undergoing fertility preservation treatments in relation to specific cancer diseases, chemotherapy and treatment protocol and the number of children. The following methods will be involved: First, previously published data will be systematically analysed regarding the gonadotoxicity of chemo- and radiotherapies in cancer patients. Second, a prospective cohort study will be set up by approximately 70 centres in Germany, Switzerland and Austria and the following data will be collected: evaluation of ovarian function by analysing AMH, FSH, LH and E2 concentrations and testicular function by analysing sperm parameters, total testosterone, FSH and LH concentration just before and around 1 year after gonadotoxic therapies (short-term fertility). A follow up of these fertility parameters including the history of potential conceptions will be performed 5 and 10 years after gonadotoxic therapies (long-term fertility). Additionally, the proportion of patients undergoing fertility preserving methods as well as their efficacy and their satisfaction with the used 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. By August 1st 2023 the following steps have been achieved: Seven systematic reviews are in progress and the first systematic reviews has been submitted for publication. The prospective cohort study has just started. All Swiss and the leading ethics committees in Germany and in Austria have given their permission. 70 infertility centers have been prepared for data collection. The study registry has been set up and activated and a study website www.fertitox.ch has been uploaded. Recruitment of patients has started in August 2023 and first data will be expected to be uploaded on the Fertitox platform in 2026. Financing of the study is given by several founding bodies. The trial war registered at ClinicalTrials.gov: NCT05885048.