Impact of Gonadotoxic Therapies on Fertility

NCT05885048 | Recruiting

• 2 other identifiers: KEK Bern 2022-02284KLS 5650-08-2022
• Study Type: observational
• Target: 7,000
• Locations: 1 country
• Sites: 1

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).

Conditions

Cancer; Fertility Issues; Fertility Preservation; Toxicity Due to Chemotherapy; Toxicity Due to Radiotherapy; Effects of Immunotherapy

Keywords

Gonadotoxicity

Outcome Measures

Primary Outcomes (6)

• 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).

  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

Secondary Outcomes (6)

• Fertility preservation measures performed

  Before the start of gonadotoxic treatment

• Satisfaction with the fertility preservation counselling before the gonadotoxic treatment

  12-15 months after the end of gonadotoxic treatment

• Satisfaction with the decision to have undergone fertility preservation measures or not

  12-15 months after the end of gonadotoxic treatment

• Number of spontaneous pregnancies and children born

  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

  12-15 months, 5 years and 10 years after the end of gonadotoxic treatment

Study Arms (2)

Cancer female participants

Fertility status before and after gonadotoxic treatment

Diagnostic Test: Blood samples for analysis; Other: Satisfaction evaluation; Other: Quality of Life questionnaire

Cancer male participants

Fertility status before and after gonadotoxic treatment

Diagnostic Test: Blood samples for analysis; Diagnostic Test: Sperm samples for analysis; Other: Satisfaction evaluation; Other: Quality of Life questionnaire

Interventions

Blood samples for analysis DIAGNOSTIC_TEST

Test hormone levels in blood

Cancer female participants; Cancer male participants

Sperm samples for analysis DIAGNOSTIC_TEST

Spermiogram

Cancer male participants

Satisfaction evaluation OTHER

Participant satisfaction assessment

Cancer female participants; Cancer male participants

Quality of Life questionnaire OTHER

The World Health Organization Quality of Life Brief 26-item Version (WHOQOL-BREF)

Cancer female participants; Cancer male participants

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Cancer participants from fertility centers (Switzerland, Germany and Austria)

You may qualify if:

• 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).

You may not qualify if:

• Missing consent;
• Language barrier.

Sponsors & Collaborators

• Michael von Wolff: lead
• University of Bern: collaborator

Study Sites (1)

University Women's Hospital (Inselspital)

Bern, 3010, Switzerland

RECRUITING

Related Publications (2)

• 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.

  PMID: 38506900 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.

  PMID: 38629685 BACKGROUND

Related Links

• A platform for gonadotoxicity of cancer therapies

MeSH Terms

Conditions

Neoplasms; Infertility

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Michael von Wolff, Prof. Dr.

  Insel Gruppe AG, University Hospital Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michael von Wolff, Prof. Dr.

CONTACT

0041316321301; michael.vonwolff@insel.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med. Michael von Wolff

Study Record Dates

• First Submitted: April 16, 2023
• First Posted: June 1, 2023
• Study Start: December 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2038
• Last Updated: June 3, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)