Impact of Gonadotoxic Therapies on Fertility
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood samples for analysis, Sperm samples for analysis, Satisfaction evaluation, Quality of Life questionnaire.
- Who it may be relevant to
- Registry conditions: Cancer, Fertility Issues, Fertility Preservation, Toxicity Due to Chemotherapy. Basic parameters: 14 years — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
Overview
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).
Interventions
- Diagnostic test Blood samples for analysis
Test hormone levels in blood - Diagnostic test Sperm samples for analysis
Spermiogram - Other Satisfaction evaluation
Participant satisfaction assessment - Other Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Primary outcome measures
- Anti-Müllerian hormone (AMH) concentration in females [Time frame: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment]
- Anti-Müllerian hormone (AMH) concentration in females [Time frame: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment]
- 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]
- Sperm concentration in males [Time frame: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment]
- Sperm concentration in males [Time frame: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment]
- 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]
Secondary outcome measures (6)
- Fertility preservation measures performed [Time frame: Before the start of gonadotoxic treatment]
- Satisfaction with the fertility preservation counselling before the gonadotoxic treatment [Time frame: 12-15 months after the end of gonadotoxic treatment]
- Satisfaction with the decision to have undergone fertility preservation measures or not [Time frame: 12-15 months after the end of gonadotoxic treatment]
- Number of spontaneous pregnancies and children born [Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]
- Number of pregnancies and children born with the help of fertility preservation measures [Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]
- Quality of life assessment [Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Switzerland · 1 center
- University Women's Hospital (Inselspital) — Bern
Publications
- von Wolff M, Germeyer A, Bottcher B, Magaton IM, Marcu I, Pape J, Sanger N, Nordhoff V, Roumet M, Weidlinger S. Evaluation of the Gonadotoxicity of Cancer Therapies to Improve Counseling of Patients About Fertility and Fertility Preservation Measures: Protocol for a Retrospective Systematic Data Analysis and a Prospective Cohort Study. JMIR Res Protoc. 2024 Mar 20;13:e51145. doi: 10.2196/51145. PMID 38506900
- Weidlinger S, Graber S, Bratschi I, Pape J, Kollar A, Karrer T, von Wolff M. A Systematic Review of the Gonadotoxicity of Osteosarcoma and Ewing's Sarcoma Chemotherapies in Postpubertal Females and Males. J Adolesc Young Adult Oncol. 2024 Aug;13(4):597-606. doi: 10.1089/jayao.2023.0185. Epub 2024 Apr 17. PMID 38629685
Identifiers
NCT: NCT05885048 · KEK Bern 2022-02284 · KLS 5650-08-2022