Impact of Gonadotoxic Therapies on Fertility (FertiTOX)

May 31, 2024 updated by: Michael von Wolff

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Observational

Enrollment (Estimated)

7000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Cancer participants from fertility centers (Switzerland, Germany and Austria)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer female participants
Fertility status before and after gonadotoxic treatment
Diagnostic test: Blood samples for analysis
Test hormone levels in blood
Other: Satisfaction evaluation
Participant satisfaction assessment
Other: Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Cancer male participants
Fertility status before and after gonadotoxic treatment
Diagnostic test: Blood samples for analysis
Test hormone levels in blood
Other: Satisfaction evaluation
Participant satisfaction assessment
Diagnostic test: Sperm samples for analysis
Spermiogram
Other: Quality of Life questionnaire
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change from baseline in AMH concentration at 12-15 months after the end of gonadotoxic treatment
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).
Change in AMH concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
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).
Change in AMH concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment
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).
Change from baseline in sperm concentration at 12-15 months after the end of gonadotoxic treatment
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).
Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment
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).
Change in sperm concentration at 10 years after time point 12-15 months after the end of gonadotoxic treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Before the start of gonadotoxic treatment
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).
12-15 months after the end of gonadotoxic treatment
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).
12-15 months after the end of gonadotoxic treatment
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.
12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
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).
12-15 months, 5 years and 10 years after the end of gonadotoxic treatment
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.
12-15 months, 5 years and 10 years after the end of gonadotoxic treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Michael von Wolff

Collaborators

University of Bern

Investigators

  • Principal Investigator: Michael von Wolff, Prof. Dr., Insel Gruppe AG, University Hospital Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2038

Study Registration Dates

First Submitted

April 16, 2023

First Submitted That Met QC Criteria

May 22, 2023

First Posted (Actual)

June 1, 2023

Study Record Updates

Last Update Posted (Actual)

June 3, 2024

Last Update Submitted That Met QC Criteria

May 31, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK Bern 2022-02284
  • KLS 5650-08-2022 (Other Identifier: Krebsliga)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Study Data/Documents

  1. Study Protocol

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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