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Recruiting NCT05885048

NCT05885048 Impact of Gonadotoxic Therapies on Fertility

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Clinical Trial Summary
NCT ID NCT05885048
Status Recruiting
Phase
Sponsor Michael von Wolff
Condition Cancer
Study Type OBSERVATIONAL
Enrollment 7,000 participants
Start Date 2023-12-01
Primary Completion 2028-12-31

Trial Parameters

Condition Cancer
Sponsor Michael von Wolff
Study Type OBSERVATIONAL
Phase N/A
Enrollment 7,000
Sex ALL
Min Age 14 Years
Max Age 50 Years
Start Date 2023-12-01
Completion 2028-12-31
Interventions
Blood samples for analysisSperm samples for analysisSatisfaction evaluation

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Brief 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).

Eligibility 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.

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