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| ID | Type | Description | Link |
|---|---|---|---|
| KLS 5650-08-2022 | Other Identifier | Krebsliga |
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| Name | Class |
|---|---|
| University of Bern | OTHER |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cancer female participants | Fertility status before and after gonadotoxic treatment |
| |
| Cancer male participants | Fertility status before and after gonadotoxic treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood samples for analysis | Diagnostic Test | Test hormone levels in blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Satisfaction with the fertility preservation counselling before the gonadotoxic treatment |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer participants from fertility centers (Switzerland, Germany and Austria)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Michael von Wolff, Prof. Dr. | Contact | 0041316321301 | michael.vonwolff@insel.ch |
| Name | Affiliation | Role |
|---|---|---|
| Michael von Wolff, Prof. Dr. | Insel Gruppe AG, University Hospital Bern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Women's Hospital (Inselspital) | Recruiting | Bern | 3010 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38506900 | Background | von Wolff M, Germeyer A, Bottcher B, Magaton IM, Marcu I, Pape J, Sanger N, Nordhoff V, Roumet M, Weidlinger S. Evaluation of the Gonadotoxicity of Cancer Therapies to Improve Counseling of Patients About Fertility and Fertility Preservation Measures: Protocol for a Retrospective Systematic Data Analysis and a Prospective Cohort Study. JMIR Res Protoc. 2024 Mar 20;13:e51145. doi: 10.2196/51145. | |
| 38629685 |
| Label | URL |
|---|---|
| A platform for gonadotoxicity of cancer therapies | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Sperm samples for analysis | Diagnostic Test | Spermiogram |
|
| Satisfaction evaluation | Other | Participant satisfaction assessment |
|
| Quality of Life questionnaire | Other | The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF) |
|
| Change in sperm concentration at 5 years after time point 12-15 months after the end of gonadotoxic treatment |
| 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 |
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 |
| 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 |
| 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 |
| 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 |
| Quality of life assessment | 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. | 12-15 months, 5 years and 10 years after the end of gonadotoxic treatment |
| Background |
| Weidlinger S, Graber S, Bratschi I, Pape J, Kollar A, Karrer T, von Wolff M. A Systematic Review of the Gonadotoxicity of Osteosarcoma and Ewing's Sarcoma Chemotherapies in Postpubertal Females and Males. J Adolesc Young Adult Oncol. 2024 Aug;13(4):597-606. doi: 10.1089/jayao.2023.0185. Epub 2024 Apr 17. |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |