Clinical trial · Observational
Impact of Gonadotoxic Therapies on Fertility
FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
NCT05885048CI-TRIAL-00119953FertiTOXrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Effects of Immunotherapy | — | UNRESOLVED | — |
| Fertility Issues | — | UNRESOLVED | — |
| Fertility Preservation | — | UNRESOLVED | — |
| Toxicity Due to Chemotherapy | — | UNRESOLVED | — |
| Toxicity Due to Radiotherapy | — | UNRESOLVED | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood samples for analysis | Diagnostic Test | — | UNRESOLVED |
| Quality of Life questionnaire | Other | — | UNRESOLVED |
| Satisfaction evaluation | Other | — | UNRESOLVED |
| Sperm samples for analysis | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Cancer female participants
- description
- Fertility status before and after gonadotoxic treatment
- interventionNames
- Diagnostic Test: Blood samples for analysis
- Other: Satisfaction evaluation
- Other: Quality of Life questionnaire
- label
- Cancer male participants
- description
- Fertility status before and after gonadotoxic treatment
- interventionNames
- Diagnostic Test: Blood samples for analysis
- Diagnostic Test: Sperm samples for analysis
- Other: Satisfaction evaluation
- Other: Quality of Life questionnaire
Primary outcomes (6)
- measure
- Anti-Müllerian hormone (AMH) concentration in females
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 50 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDvon 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. PMID 38506900
- BACKGROUNDWeidlinger 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. PMID 38629685