Quality of Life questionnaire: The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Study 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).
Eligibility
Sex
ALL
Min age
14 Years
Max age
50 Years
Healthy volunteers
No
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 outcome measure(s)
Anti-Müllerian hormone (AMH) concentration in females — Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment 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).
Anti-Müllerian hormone (AMH) concentration in females — Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment 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).
Anti-Müllerian hormone (AMH) concentration in females — Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment 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).
Sperm concentration in males — Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment 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).
Sperm concentration in males — Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment 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).
Sperm concentration in males — Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment 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).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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