Ignite Creation Date:
2024-05-06 @ 7:03 PM
Last Modification Date:
2024-10-26 @ 3:00 PM
Study NCT ID:
NCT05885048
Status:
RECRUITING
Last Update Posted:
2024-06-03
First Post:
2023-04-16
Brief Title:
Impact of Gonadotoxic Therapies on Fertility
Sponsor:
Michael von Wolff
Organization:
Universitätsklinik fur Frauenheilkunde Inselspital Bern
Study Overview
Official Title:
FertiTOX - Platform for Fertility Related Gonadotoxicity of Cancer Therapies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FertiTOX
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KLS 5650-08-2022 | OTHER | Krebsliga | None |