NCT05885048: FertiTOX

Impact of Gonadotoxic Therapies on Fertility

Recruiting now Last updated 3 June 2024

What this trial tests

trial testing Blood samples for analysis in Cancer in 7,000 participants. Currently enrolling.

Timeline

1 December 2023

Primary endpoint
31 December 2028

31 December 2038

Quick facts

Lead sponsor	Michael von Wolff
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	7,000
Start date	1 December 2023
Primary completion	31 December 2028
Estimated completion	31 December 2038
Sites	1 location across Switzerland

Drugs / interventions tested

• Blood samples for analysis
• Sperm samples for analysis
• Satisfaction evaluation
• Quality of Life questionnaire

Conditions studied

• Cancer — all drugs for Cancer →
• Fertility Issues — all drugs for Fertility Issues →
• Fertility Preservation — all drugs for Fertility Preservation →
• Toxicity Due to Chemotherapy — all drugs for Toxicity Due to Chemotherapy →

Sponsor

Michael von Wolff

Who can join

Adults 14 to 50, any sex, with Cancer or Fertility Issues. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   von Wolff M, Germeyer A, Böttcher B, Magaton IM, et al · · 2024 · cited 11× · PMID 38506900 · DOI 10.2196/51145