RecruitingNCT05885048

Impact of Gonadotoxic Therapies on Fertility

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies


Sponsor

Michael von Wolff

Enrollment

7,000 participants

Start Date

Dec 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 14 YearsMax Age: 50 Years

Inclusion Criteria4

  • 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 Criteria2

  • Missing consent;
  • Language barrier.

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Interventions

DIAGNOSTIC_TESTBlood samples for analysis

Test hormone levels in blood

DIAGNOSTIC_TESTSperm samples for analysis

Spermiogram

OTHERSatisfaction evaluation

Participant satisfaction assessment

OTHERQuality of Life questionnaire

The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)


Locations(1)

University Women's Hospital (Inselspital)

Bern, Switzerland

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NCT05885048


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