Impact of Gonadotoxic Therapies on Fertility (FertiTOX)

Michael von Wolff

Status

Enrolling

Conditions

Effects of Immunotherapy

Toxicity Due to Radiotherapy

Fertility Preservation

Cancer

Fertility Issues

Toxicity Due to Chemotherapy

Treatments

Other: Quality of Life questionnaire

Diagnostic Test: Sperm samples for analysis

Other: Satisfaction evaluation

Diagnostic Test: Blood samples for analysis

Study type

Observational

Funder types

Other

Identifiers

NCT05885048

KEK Bern 2022-02284

KLS 5650-08-2022 (Other Identifier)

Details and patient eligibility

About

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).

Full 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).

Enrollment

7,000 estimated patients

Sex

All

Ages

14 to 50 years old

Volunteers

No Healthy Volunteers

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