CancerFertiTOXNCT05885048
Impact of Gonadotoxic Therapies on Fertility
An observational study of Cancer and Fertility Issues, run by Michael von Wolff at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 50 years
- Conditions the study is for
- Cancer, Fertility Issues, Fertility Preservation
- What is being tested?
- Blood samples for analysis, Sperm samples for analysis and Satisfaction evaluation
- How many people
- 7,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Dec 2023to 31 Dec 2038
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Cancer participants from fertility centers (Switzerland, Germany and Austria)
Who may be able to join
- 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).
Who cannot join
- Missing consent;
- Language barrier.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
University Women's Hospital (Inselspital)
Bern, 3010
Michael von Wolff, Prof. Dr., + 41 31 632 13 01, michael.vonwolff@insel.ch
Irene Marcu, PhD, irene.marcu@insel.ch
About this study
Official title: 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).
Read the 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).
- Conditions
- Cancer, Fertility Issues, Fertility Preservation, Toxicity Due to Chemotherapy, Toxicity Due to Radiotherapy, Effects of Immunotherapy
- Being tested
- Blood samples for analysis, Sperm samples for analysis, Satisfaction evaluation, Quality of Life questionnaire
- Keywords
- Gonadotoxicity
- Medical subject headings
- Neoplasms, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samples for analysisDiagnostic test
Test hormone levels in blood
Sperm samples for analysisDiagnostic test
Spermiogram
Satisfaction evaluationOther
Participant satisfaction assessment
Quality of Life questionnaireOther
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
| Study group | Role | What they receive |
|---|---|---|
| Cancer female participants | Fertility status before and after gonadotoxic treatment Receives: Diagnostic Test: Blood samples for analysis; Other: Satisfaction evaluation; Other: Quality of Life questionnaire | |
| Cancer male participants | Fertility status before and after gonadotoxic treatment Receives: Diagnostic Test: Blood samples for analysis; Diagnostic Test: Sperm samples for analysis; Other: Satisfaction evaluation; Other: Quality of Life questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
Secondary outcomes (6)
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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
Quality of life assessment
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.
Measured: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2023
- Study start1 Dec 2023
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Michael von Wolff
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bern
- Responsible party
- Sponsor-investigator, Michael von Wolff, Universitätsklinik fur Frauenheilkunde, Inselspital Bern
- Investigators
- Michael von Wolff, Prof. Dr., Principal investigator, Insel Gruppe AG, University Hospital Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05885048
- Sponsor's protocol ID
- KEK Bern 2022-02284
- Other IDs
- KLS 5650-08-2022
- Acronym
- FertiTOX
- Status last verified
- Jul 2026
- First submitted
- 16 Apr 2023
- Last updated
- 30 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
von Wolff M, Germeyer A, Bottcher B, Magaton IM, Marcu I, Pape J, Sanger N, Nordhoff V, Roumet M, Weidlinger S. Evaluation of the Gonadotoxicity of Cancer Therapies to Improve Counseling of Patients About Fertility and Fertility Preservation Measures: Protocol for a Retrospective Systematic Data Analysis and a Prospective Cohort Study. JMIR Res Protoc. 2024 Mar 20;13:e51145. doi: 10.2196/51145.
PubMed 38506900Weidlinger S, Graber S, Bratschi I, Pape J, Kollar A, Karrer T, von Wolff M. A Systematic Review of the Gonadotoxicity of Osteosarcoma and Ewing's Sarcoma Chemotherapies in Postpubertal Females and Males. J Adolesc Young Adult Oncol. 2024 Aug;13(4):597-606. doi: 10.1089/jayao.2023.0185. Epub 2024 Apr 17.
PubMed 38629685
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
- ClinicalTrials.gov ID
- NCT05885048
- Acronym / sponsor ID
- FertiTOX / KEK Bern 2022-02284
- Conditions
- Cancer, Fertility Issues, Fertility Preservation, Toxicity Due to Chemotherapy, Toxicity Due to Radiotherapy, Effects of Immunotherapy
- Keywords
- Gonadotoxicity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 7,000 participants (estimated)
- Lead sponsor
- Michael von WolffUniversity, hospital or other
- Collaborators
- University of Bern
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2038 (estimated)
- First posted
- 1 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cancer female participants | – | Diagnostic Test: Blood samples for analysis, Other: Satisfaction evaluation, Other: Quality of Life questionnaireFertility status before and after gonadotoxic treatment |
| Cancer male participants | – | Diagnostic Test: Blood samples for analysis, Diagnostic Test: Sperm samples for analysis, Other: Satisfaction evaluation, Other: Quality of Life questionnaireFertility status before and after gonadotoxic treatment |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Cancer participants from fertility centers (Switzerland, Germany and Austria)
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (2 listed)
- Missing consent;
- Language barrier.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samples for analysisTest hormone levels in blood | Diagnostic test | Cancer female participants, Cancer male participants |
| Sperm samples for analysisSpermiogram | Diagnostic test | Cancer male participants |
| Satisfaction evaluationParticipant satisfaction assessment | Other | Cancer female participants, Cancer male participants |
| Quality of Life questionnaireThe World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF) | Other | Cancer female participants, Cancer male participants |
Primary outcome
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).
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).
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).
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).
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).
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).
6 secondary outcomes
Fertility preservation measures performed
Time frame: 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
Satisfaction with the decision to have undergone fertility preservation measures or not
Time frame: 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
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
Quality of life assessment
Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Background: PubMed 38506900von Wolff M, Germeyer A, Bottcher B, Magaton IM, Marcu I, Pape J, Sanger N, Nordhoff V, Roumet M, Weidlinger S. Evaluation of the Gonadotoxicity of Cancer Therapies to Improve Counseling of Patients About Fertility and Fertility Preservation Measures: Protocol for a Retrospective Systematic Data Analysis and a Prospective Cohort Study. JMIR Res Protoc. 2024 Mar 20;13:e51145. doi: 10.2196/51145.
- Background: PubMed 38629685Weidlinger S, Graber S, Bratschi I, Pape J, Kollar A, Karrer T, von Wolff M. A Systematic Review of the Gonadotoxicity of Osteosarcoma and Ewing's Sarcoma Chemotherapies in Postpubertal Females and Males. J Adolesc Young Adult Oncol. 2024 Aug;13(4):597-606. doi: 10.1089/jayao.2023.0185. Epub 2024 Apr 17.
- A platform for gonadotoxicity of cancer therapiesLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael von Wolff, Prof. Dr. principal investigator
Insel Gruppe AG, University Hospital Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Fertility Issues, run by Michael von Wolff at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael von Wolff, Prof. Dr. (0041316321301, michael.vonwolff@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05885048, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.