- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05885048
Impact of Gonadotoxic Therapies on Fertility (FertiTOX)
FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
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).
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Michael von Wolff, Prof. Dr.
- Phone Number: 0041316321301
- Email: michael.vonwolff@insel.ch
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cancer female participants
Fertility status before and after gonadotoxic treatment
|
Test hormone levels in blood
Participant satisfaction assessment
Short-Form 12-items health survey (SF-12)
|
Cancer male participants
Fertility status before and after gonadotoxic treatment
|
Test hormone levels in blood
Participant satisfaction assessment
Short-Form 12-items health survey (SF-12)
Spermiogram
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Anti-Müllerian hormone (AMH) concentration in females
Time Frame: 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). |
Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment
|
Anti-Müllerian hormone (AMH) concentration in females
Time Frame: 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). |
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
Time Frame: 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). |
Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
|
Sperm concentration in males
Time Frame: 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). |
Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
|
Sperm concentration in males
Time Frame: 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). |
Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
|
Sperm concentration in males
Time Frame: 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). |
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
Time Frame: 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. |
Before the start of gonadotoxic treatment
|
Satisfaction with the fertility preservation counselling before the gonadotoxic treatment
Time Frame: 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).
|
12-15 months after the end of gonadotoxic treatment
|
Satisfaction with the decision to have undergone fertility preservation measures or not
Time Frame: 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).
|
12-15 months after the end of gonadotoxic treatment
|
Number of spontaneous pregnancies and children born
Time Frame: 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.
|
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
Time Frame: 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).
|
12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
|
Quality of life assessment
Time Frame: 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).
|
12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Michael von Wolff, Prof. Dr., University Hospital Inselspital, Berne
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK Bern 2022-02284
- KLS 5650-08-2022 (Other Identifier: Krebsliga)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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