Impact of Gonadotoxic Therapies on Fertility

Study Overview
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Brief Summary
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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
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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).

Official Title
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FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

Conditions
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Cancer, Fertility Issues, Fertility Preservation, Toxicity Due to Chemotherapy, Toxicity Due to Radiotherapy, Effects of Immunotherapy

Intervention / Treatment
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* Diagnostic Test: Blood samples for analysis
* Diagnostic Test: Sperm samples for analysis
* Other: Satisfaction evaluation
* Other: Quality of Life questionnaire


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing to participate; Participants aged between 14 and 50 years (adolescents and adults); Participants undergoing cancer therapies (or gonadotoxic treatment) using chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immunotherapy; Participants undergoing chemotherapies for benign reasons; Female participants: serum hormone analysis before gonadotoxic treatment; Male participants: serum hormone analysis and sperm analysis before gonadotoxic treatment. Exclusion Criteria: Not willing to participate; Missing consent; Language barrier.

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer female participants<br>Fertility status before and after gonadotoxic treatment | Diagnostic Test: Blood samples for analysis<br>* Test hormone levels in blood<br>Other: Satisfaction evaluation<br>* Participant satisfaction assessment<br>Other: Quality of Life questionnaire<br>* Short-Form 12-items health survey (SF-12)<br>|
| Cancer male participants<br>Fertility status before and after gonadotoxic treatment | Diagnostic Test: Blood samples for analysis<br>* Test hormone levels in blood<br>Diagnostic Test: Sperm samples for analysis<br>* Spermiogram<br>Other: Satisfaction evaluation<br>* Participant satisfaction assessment<br>Other: Quality of Life questionnaire<br>* Short-Form 12-items health survey (SF-12)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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). | 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). | 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). | 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). | 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). | Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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). | 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. | 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). | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment | 
| Quality of life assessment | 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). | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gonadotoxicity