Cancer, Effects of Immunotherapy, Fertility Issues, Fertility Preservation, Toxicity Due to Chemotherapy, Toxicity Due to Radiotherapy
Conditions
Keywords
Gonadotoxicity
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).
Interventions
DIAGNOSTIC_TESTBlood samples for analysis
Test hormone levels in blood
DIAGNOSTIC_TESTSperm samples for analysis
Spermiogram
Participant satisfaction assessment
OTHERQuality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Sponsors
Michael von Wolff
University of Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fertility preservation measures performed | Before the start of gonadotoxic treatment | 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 | 12-15 months after the end of 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 | 12-15 months after the end of gonadotoxic treatment | 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 | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment | Pregnancies which occured naturally, without the help of fertility preservation measures. |
| Number of pregnancies and children born with the help of fertility preservation measures | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment | 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). |
| Quality of life assessment | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment | 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. |
Countries
Switzerland
Contacts
CONTACTMichael von Wolff, Prof. Dr.
PRINCIPAL_INVESTIGATORMichael von Wolff, Prof. Dr.
Insel Gruppe AG, University Hospital Bern
Outcome results
None listed