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Trial Title:
Impact of Gonadotoxic Therapies on Fertility
NCT ID:
NCT05885048
Condition:
Cancer
Fertility Issues
Fertility Preservation
Toxicity Due to Chemotherapy
Toxicity Due to Radiotherapy
Effects of Immunotherapy
Conditions: Official terms:
Infertility
Conditions: Keywords:
Gonadotoxicity
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Blood samples for analysis
Description:
Test hormone levels in blood
Arm group label:
Cancer female participants
Arm group label:
Cancer male participants
Intervention type:
Diagnostic Test
Intervention name:
Sperm samples for analysis
Description:
Spermiogram
Arm group label:
Cancer male participants
Intervention type:
Other
Intervention name:
Satisfaction evaluation
Description:
Participant satisfaction assessment
Arm group label:
Cancer female participants
Arm group label:
Cancer male participants
Intervention type:
Other
Intervention name:
Quality of Life questionnaire
Description:
The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)
Arm group label:
Cancer female participants
Arm group label:
Cancer male participants
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).
Criteria for eligibility:
Study pop:
Cancer participants from fertility centers (Switzerland, Germany and Austria)
Sampling method:
Non-Probability Sample
Criteria:
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.
Gender:
All
Minimum age:
14 Years
Maximum age:
50 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University Women's Hospital (Inselspital)
Address:
City:
Bern
Zip:
3010
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Michael von Wolff, Prof. Dr.
Phone:
+ 41 31 632 13 01
Email:
michael.vonwolff@insel.ch
Contact backup:
Last name:
Irene Marcu, PhD
Email:
irene.marcu@insel.ch
Start date:
December 1, 2023
Completion date:
December 31, 2038
Lead sponsor:
Agency:
Michael von Wolff
Agency class:
Other
Collaborator:
Agency:
University of Bern
Agency class:
Other
Source:
Universitätsklinik fur Frauenheilkunde, Inselspital Bern
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05885048
https://fertitox.com/
