FertiTOX: Impact of Gonadotoxic Therapies on Fertility
Study Details
Study Description
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:
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in females, if cancer therapies reduce the Anti-Müllerian hormone (AMH) concentration (ovarian reserve);
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in males, if cancer therapies reduce sperm concentration (sperm quality).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer female participants Fertility status before and after gonadotoxic treatment |
Diagnostic Test: Blood samples for analysis
Test hormone levels in blood
Other: Satisfaction evaluation
Participant satisfaction assessment
Other: Quality of Life questionnaire
Short-Form 12-items health survey (SF-12)
|
| Cancer male participants Fertility status before and after gonadotoxic treatment |
Diagnostic Test: Blood samples for analysis
Test hormone levels in blood
Diagnostic Test: Sperm samples for analysis
Spermiogram
Other: Satisfaction evaluation
Participant satisfaction assessment
Other: Quality of Life questionnaire
Short-Form 12-items health survey (SF-12)
|
Outcome Measures
Primary Outcome Measures
- 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).
Secondary Outcome Measures
- 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]
Short-Form 12-items health survey (SF-12, version 2) is a questionnaire that consists of 12 questions. It investigates the participant's state of health through 8 different dimensions: general health perception (1 question), physical health (2 questions), limited physical role function (2 questions), physical pain (1 question), vitality (1 question), mental health (2 questions), limited emotional role function (2 questions) and social functioning (1 question).
Eligibility Criteria
Criteria
Inclusion Criteria:
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Willing to participate;
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Participants aged between 14 and 50 years (adolescents and adults);
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Participants undergoing cancer therapies (or gonadotoxic treatment) using chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immunotherapy;
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Participants undergoing chemotherapies for benign reasons;
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Female participants: serum hormone analysis before gonadotoxic treatment;
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Male participants: serum hormone analysis and sperm analysis before gonadotoxic treatment.
Exclusion Criteria:
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Not willing to participate;
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Missing consent;
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Language barrier.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Michael von Wolff
- University of Bern
Investigators
- Principal Investigator: Michael von Wolff, Prof. Dr., University Hospital Inselspital, Berne
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KEK Bern 2022-02284
- KLS 5650-08-2022