Effects of cancer treatments on fertility
FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
This study looks at how cancer treatments like chemotherapy and radiation affect fertility in both men and women by checking hormone and sperm levels before and after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 7000 (estimated) |
| Ages | 14 Years to 50 Years |
| Sex | All |
| Sponsor | Universitätsklinik fur Frauenheilkunde, Inselspital Bern Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Bern) |
| Trial ID | NCT05885048 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate how gonadotoxic treatments, such as chemotherapy and radiotherapy, impact fertility in cancer patients. It focuses on measuring changes in Anti-Müllerian hormone (AMH) levels in females and sperm concentration in males before and after treatment. The study will collect fertility-related data from various centers in Switzerland, Germany, and Austria over a period of up to 15 years. Data will be gathered through routine clinical care and analyzed to understand the long-term effects of these therapies on reproductive health.
Who should consider this trial
Good fit: Ideal candidates include cancer patients aged 14-50 in Austria and Switzerland, and 18-50 in Germany, who are undergoing gonadotoxic therapies.
Not a fit: Patients who do not consent to participate or have language barriers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into fertility preservation strategies for cancer patients undergoing gonadotoxic treatments.
How similar studies have performed: Other studies have shown varying degrees of success in understanding the impact of gonadotoxic therapies on fertility, making this approach both relevant and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Bern
- University Women's Hospital (Inselspital) — Bern, Switzerland (Recruiting)
Study contacts
- Principal investigator: Michael von Wolff, Prof. Dr. — Insel Gruppe AG, University Hospital Bern
- Study coordinator: Michael von Wolff, Prof. Dr.
- Email: michael.vonwolff@insel.ch
- Phone: 0041316321301
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.