Actively Recruiting
Led by Michael von Wolff · Updated on 2024-06-03
7000
Participants Needed
1
Research Sites
521 weeks
Total Duration
M
Michael von Wolff
Lead Sponsor
U
University of Bern
Collaborating Sponsor
Researchers are investigating how cancer treatments that may harm fertility, such as chemotherapy, radiotherapy, and immunotherapy, impact the fertility status of patients with cancer. The study focuses on females to see if these treatments reduce Anti-Müllerian hormone (AMH) levels, which indicate ovarian reserve, and on males to assess changes in sperm concentration. This international observational study involves multiple fertility centers in Switzerland, Germany, Austria, and other interested countries. Participants will have their fertility data collected before starting gonadotoxic treatments and followed up for years afterward. Data collection occurs before treatment for up to five years and after treatment at 12-15 months, 5 years, and 10 years. The study gathers routine clinical information such as blood hormone levels, sperm samples, and surveys about satisfaction and quality of life. Participants include both females and males with cancer undergoing gonadotoxic therapies. Throughout the study, participants will provide blood samples for hormone testing and sperm samples for analysis. They will complete questionnaires on satisfaction with fertility preservation counseling and quality of life assessments at set intervals after treatment. Researchers will track changes in AMH levels and sperm concentration over time, as well as pregnancy outcomes. The study lasts up to 15 years, allowing long-term monitoring of fertility effects following cancer treatments.
CONDITIONS
Impact of Gonadotoxic Therapies on Fertility
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 5 years
Participants undergo fertility assessments including blood and sperm sample analysis before starting gonadotoxic treatment.
Data collection mostly through routine clinical care visits
Duration - 10 years
Participants are monitored after the end of gonadotoxic treatment with follow-up assessments of fertility and quality of life.
Visits at 12-15 months, 5 years, and 10 years after treatment completion
Total: 1 location
1
University Women's Hospital (Inselspital)
Bern, Switzerland, 3010
Actively Recruiting
M
Michael von Wolff, Prof. Dr.
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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https://pubmed.ncbi.nlm.nih.gov/38506900Susanna Weidlinger, Satu Graber, Irina Bratschi...
https://pubmed.ncbi.nlm.nih.gov/38629685