Impact of Gonadotoxic Therapies on Fertility

Recruiting

• Conditions: Fertility Preservation; Toxicity Due to Chemotherapy; Cancer; Toxicity Due to Radiotherapy; Effects of Immunotherapy; Fertility Issues
• Interventions: Diagnostic Test: Blood samples for analysis; Other: Satisfaction evaluation; Diagnostic Test: Sperm samples for analysis; Other: Quality of Life questionnaire

• Registration Number: NCT05885048
• Lead Sponsor: Michael von Wolff

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).

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 Timeline

• Study First Submitted: 2023-04-16
• Study First Submitted QC: 2023-05-22
• Study First Posted: 2023-06-01
• Study Start: 2023-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-31
• Last Update Posted: 2024-06-03
• Primary Completion: 2028-12-31
• Study Completion: 2038-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 7000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cancer female participants	Blood samples for analysis	Fertility status before and after gonadotoxic treatment
Cancer female participants	Satisfaction evaluation	Fertility status before and after gonadotoxic treatment
Cancer male participants	Blood samples for analysis	Fertility status before and after gonadotoxic treatment
Cancer female participants	Quality of Life questionnaire	Fertility status before and after gonadotoxic treatment
Cancer male participants	Sperm samples for analysis	Fertility status before and after gonadotoxic treatment
Cancer male participants	Satisfaction evaluation	Fertility status before and after gonadotoxic treatment
Cancer male participants	Quality of Life questionnaire	Fertility status before and after gonadotoxic treatment

Primary Outcome Measures

Name	Time	Method
Sperm concentration in males	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).
Anti-Müllerian hormone (AMH) concentration in females	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).

Secondary Outcome Measures

Name	Time	Method
Number of pregnancies and children born with the help of fertility preservation measures	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).
Fertility preservation measures performed	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.
Satisfaction with the decision to have undergone fertility preservation measures or not	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).
Satisfaction with the fertility preservation counselling before the gonadotoxic treatment	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).
Number of spontaneous pregnancies and children born	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.
Quality of life assessment	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.

Trial Locations

Locations (1)

University Women's Hospital (Inselspital); 🇨🇭 Bern, Switzerland