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).
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).
Missing consent;
Language barrier.
Cancer participants from fertility centers (Switzerland, Germany and Austria)
Cohort
Prospective
Blood samples for analysis
Diagnostic testTest hormone levels in blood
Sperm samples for analysis
Diagnostic testSpermiogram
Satisfaction evaluation
Other interventionParticipant satisfaction assessment
Quality of Life questionnaire
Other interventionThe World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
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).
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).
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).
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).
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.
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).
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).
Number of spontaneous pregnancies and children born
Pregnancies which occured naturally, without the help of fertility preservation measures.
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Michael von Wolff
Lead sponsor
Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Sponsor institution
University of Bern
Collaborator
