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NCT Number: NCT05885048

Impact of Gonadotoxic Therapies on Fertility

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).

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Key information

Conditions

Cancer Effects of Immunotherapy Fertility Issues Fertility Preservation Genital Diseases Infertility Neoplasms Toxicity Due to Chemotherapy Toxicity Due to Radiotherapy Urogenital Diseases

Age range

14 year–50 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

This is an international multicenter prospective exploratory study of fertility related data generated mostly routinely in fertility centers in Switzerland belonging to the Swiss network "FertiSAVE" as well as in fertility centers in Germany and Austria belonging to the German-Swiss-Austrian network "FertiPROTEKT" and further international centers who are interested to participate. Both networks include in total around 200 centers.

The data, which are mainly part of the routine clinical care, will be collected by the physicians and added to the REDcap study registry. Patients will be coded by the center to be able to follow them up. Each center will only have access to its own registry data set. Access to the total data set is only permitted for the principal investigator and the specific sub-investigators.

Data collection before the start of gonadotoxic treatment will be performed for 5 years.

Data collection after the end of gonadotoxic treatment will be performed for 10 years (time points: at 12-15 months, at 5 years and at 10 years).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood samples for analysis

Diagnostic Test

Test hormone levels in blood

Sperm samples for analysis

Diagnostic Test

Spermiogram

Satisfaction evaluation

Other

Participant satisfaction assessment

Quality of Life Questionnaire

Other

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

Primary outcomes

  1. Anti-Müllerian hormone (AMH) concentration in females

    Time frame: Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in females (referring to ovarian reserve).

    Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).

  2. Anti-Müllerian hormone (AMH) concentration in females

    Time frame: Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in females (referring to ovarian reserve).

    Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).

  3. Anti-Müllerian hormone (AMH) concentration in females

    Time frame: Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in females (referring to ovarian reserve).

    Blood will be drawn to measure AMH concentration. Unit of measure: for serum AMH value is picomol per liter (pmol/L).

  4. Sperm concentration in males

    Time frame: Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in males (referring to sperm quality).

    Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10^6/mL).

  5. Sperm concentration in males

    Time frame: Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in males (referring to sperm quality).

    Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10^6/mL).

  6. Sperm concentration in males

    Time frame: Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment

    Fertility status after gonadotoxic treatment in males (referring to sperm quality).

    Participants provide the laboratory with a sperm sample for analysis. Unit of measure: for sperm concentration is millions per milliliter (10^6/mL).

Secondary outcomes

  1. Fertility preservation measures performed

    Time frame: Before the start of gonadotoxic treatment

    Proportion of female participants who freeze their ovarian tissue, oocytes, zygotes or embryos.

    Proportion of male participants who freeze their sperm or testicular tissue.

  2. Satisfaction with the fertility preservation counselling before the gonadotoxic treatment

    Time frame: 12-15 months after the end of gonadotoxic treatment

    Both female and male participants will have to rate their counselling satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).

  3. Satisfaction with the decision to have undergone fertility preservation measures or not

    Time frame: 12-15 months after the end of gonadotoxic treatment

    Both female and male participants will have to rate their decisional satisfaction by choosing a score on a scale from 1 to 10. Value 1, being the lowest score (not satisfied at all) and value 10 being the highest score (very satisfied).

  4. Number of spontaneous pregnancies and children born

    Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment

    Pregnancies which occured naturally, without the help of fertility preservation measures.

  5. Number of pregnancies and children born with the help of fertility preservation measures

    Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment

    Pregnancies which occured with the help of fertility preservation measures (in females: frozen ovarian tissue, oocytes, zygotes or embryos, and in males: frozen sperm or testicular tissue).

  6. Quality of life assessment

    Time frame: 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment

    The World Health Organization Quality of Life Brief 26-item version (WHOQOL-BREF) is a 26-item instrument consisting of four domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items), while the remaining two items are for the overall QoL and general health domains.

Study contacts

Contact information is provided by the study sponsor or research team.

Michael von Wolff, Prof. Dr.

CONTACT

[email protected]

0041316321301

Sponsors and collaborators

Lead sponsor

Michael von Wolff

Other

Collaborators

  • University of Bern

Registry information

Official study title

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

Acronym: FertiTOX

Important dates

Study start
2023
Primary completion
2028
Study completion
2038
First posted
Jun 1, 2023
Registry last updated
Jul 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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