Impact of Gonadotoxic Therapies on Fertility

Cancer Clinical Trial

— FertiTOX  

Official title:

FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05885048
• Other study ID #: KEK Bern 2022-02284
• Secondary ID: KLS 5650-08-2022
• Status: Not yet recruiting
• Start date: June 1, 2023
• Est. completion date: December 31, 2038

Study information

• Verified date: May 2023
• Source: Universitätsklinik fur Frauenheilkunde, Inselspital Bern
• Contact: Michael von Wolff, Prof. Dr.
• Phone: 0041316321301
• Email: michael.vonwolff[@]insel.ch
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 7000
• Est. completion date: December 31, 2038
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years to 50 Years

Eligibility

Inclusion Criteria:

• Willing to participate;
• Participants aged between 14 and 50 years (adolescents and adults);
• Participants undergoing cancer therapies (or gonadotoxic treatment) using chemotherapy and/or radiotherapy of the pelvis (females) and the testicles (males) and/or immunotherapy;
• Participants undergoing chemotherapies for benign reasons;
• Female participants: serum hormone analysis before gonadotoxic treatment;
• Male participants: serum hormone analysis and sperm analysis before gonadotoxic treatment.

Exclusion Criteria:

• Not willing to participate;
• Missing consent;
• Language barrier.

Related Conditions & MeSH terms

• Cancer
• Effects of Immunotherapy
• Fertility Issues
• Fertility Preservation
• Infertility
• Toxicity Due to Chemotherapy
• Toxicity Due to Radiotherapy

Intervention

Diagnostic Test:
• Blood samples for analysis
Test hormone levels in blood
• Sperm samples for analysis
Spermiogram

Other:
• Satisfaction evaluation
Participant satisfaction assessment
• Quality of Life questionnaire
Short-Form 12-items health survey (SF-12)

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Michael von Wolff	University of Bern

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anti-Müllerian hormone (AMH) concentration in females	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
Primary	Anti-Müllerian hormone (AMH) concentration in females	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
Primary	Anti-Müllerian hormone (AMH) concentration in females	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
Primary	Sperm concentration in males	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
Primary	Sperm concentration in males	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
Primary	Sperm concentration in males	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	Fertility preservation measures performed	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
Secondary	Satisfaction with the fertility preservation counselling before the 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
Secondary	Satisfaction with the decision to have undergone fertility preservation measures or not	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
Secondary	Number of spontaneous pregnancies and children born	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
Secondary	Number of pregnancies and children born with the help of fertility preservation measures	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
Secondary	Quality of life assessment	Short-Form 12-items health survey (SF-12, version 2) is a questionnaire that consists of 12 questions. It investigates the participant's state of health through 8 different dimensions: general health perception (1 question), physical health (2 questions), limited physical role function (2 questions), physical pain (1 question), vitality (1 question), mental health (2 questions), limited emotional role function (2 questions) and social functioning (1 question).	12-15 months, 5 years and 10 years after the end of gonadotoxic treatment