Impact of Gonadotoxic Therapies on Fertility (NCT05885048) | Clinical Trial Compass
RecruitingNot Applicable
Impact of Gonadotoxic Therapies on Fertility
Switzerland7,000 participantsStarted 2023-12-01
Plain-language 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).
Who can participate
Age range
14 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is tracking AMH levels in women and sperm concentration in men over time — does my specific cancer treatment plan put me at enough risk for fertility damage that joining this kind of monitoring study would actually give us useful information about my situation?
2Since this trial isn't testing a new treatment but instead measuring how chemo, radiation, or immunotherapy affects fertility markers, would participating require any extra procedures beyond what I'd already be getting, and how often would those measurements be taken?
3AMH is being used here as a marker of ovarian reserve — given my age and baseline fertility status, how meaningful would changes in my AMH levels actually be for predicting my long-term fertility, and is that something my care team would act on?
4Before or alongside joining this study, should I be talking to a reproductive specialist about fertility preservation options like egg or sperm freezing, especially if my treatment is starting soon?
5Since this is a recruiting observational study rather than a treatment trial, what would I realistically gain from participating compared to simply having my fertility monitored as part of my standard care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anti-Müllerian hormone (AMH) concentration in females
Timeframe: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment
2
Anti-Müllerian hormone (AMH) concentration in females
Timeframe: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
3
Anti-Müllerian hormone (AMH) concentration in females
Timeframe: Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
4
Sperm concentration in males
Timeframe: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
5
Sperm concentration in males
Timeframe: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
6
Sperm concentration in males
Timeframe: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment