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).
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).
Study Type
OBSERVATIONAL
Enrollment
7,000
Test hormone levels in blood
Spermiogram
Participant satisfaction assessment
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
University Women's Hospital (Inselspital)
Bern, Switzerland
RECRUITINGAnti-Müllerian hormone (AMH) concentration in females
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
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
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
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
Fertility status after gonadotoxic treatment in females (referring to ovarian reserve). Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).
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
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
Time frame: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
Sperm concentration in males
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
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
Fertility status after gonadotoxic treatment in males (referring to sperm quality). Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10\^6/mL).
Time frame: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
Fertility preservation measures performed
Proportion of female participants who freeze their ovarian tissue, oocytes, zygotes or embryos. Proportion of male participants who freeze their sperm or testicular tissue.
Time frame: Before the start of gonadotoxic treatment
Satisfaction with the fertility preservation counselling before the gonadotoxic treatment
Both female and male participants will have to rate their counselling satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).
Time frame: 12-15 months after the end of gonadotoxic treatment
Satisfaction with the decision to have undergone fertility preservation measures or not
Both female and male participants will have to rate their decisional satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).
Time frame: 12-15 months after the end of gonadotoxic treatment
Number of spontaneous pregnancies and children born
Pregnancies which occured naturally, without the help of fertility preservation measures.
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
Pregnancies which occured with the help of fertility preservation measures (in females: frozen ovarian tissue, oocytes, zygotes or embryos, and in males: frozen sperm or testicular tissue).
Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
Quality of life assessment
The World Health Organization Quality of Life Brief 26-item version (WHOQOL-BREF) is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items), while the remaining two items are for the overall QoL and general health domains.
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Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment