Clinical trial NCT05885048: Impact of Gonadotoxic Therapies on Fertility
Official title: FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Fertility Issues
Fertility Preservation
Toxicity Due to Chemotherapy
Toxicity Due to Radiotherapy
Effects of Immunotherapy
Keywords: Gonadotoxicity
Lead sponsor: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Sponsor class: OTHER
Collaborators: name: University of Bern
First posted: 2023-06-01
Enrollment: 7000
Sex: ALL
Minimum age (years): 14
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cancer participants from fertility centers (Switzerland, Germany and Austria)

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).

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.

Primary outcomes:
measure: Anti-Müllerian hormone (AMH) concentration in females
timeFrame: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment
measure: Anti-Müllerian hormone (AMH) concentration in females
timeFrame: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
measure: Anti-Müllerian hormone (AMH) concentration in females
timeFrame: Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
measure: Sperm concentration in males
timeFrame: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
measure: Sperm concentration in males
timeFrame: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
measure: Sperm concentration in males
timeFrame: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
Secondary outcomes:
measure: Fertility preservation measures performed
timeFrame: Before the start of gonadotoxic treatment
measure: Satisfaction with the fertility preservation counselling before the gonadotoxic treatment
timeFrame: 12-15 months after the end of gonadotoxic treatment
measure: Satisfaction with the decision to have undergone fertility preservation measures or not
timeFrame: 12-15 months after the end of gonadotoxic treatment
measure: Number of spontaneous pregnancies and children born
timeFrame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
measure: Number of pregnancies and children born with the help of fertility preservation measures
timeFrame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
measure: Quality of life assessment
timeFrame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Women's Hospital (Inselspital)
Study officials:
affiliation: Insel Gruppe AG, University Hospital Bern
name: Michael von Wolff, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.