Survey of Patients Who Received Fertility Preservation Counseling and Underwent Testicular Tissue Cryopreservation Prior to Gonadotoxic Treatment During Childhood or Peripuberty

NCT07140549 | Enrolling By Invitation DMC

• 1 other identifier: 2023/14JUI/263
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy and radiotherapy can lead to spermatogonial stem cell depletion in pre- and peripubertal boys, potentially resulting in infertility during adulthood A testicular biopsy is considered a safe procedure performed in children prior to gonadotoxic treatment as part of a fertility preservation strategy. At the time of the procedure, parental involvement is essential-both in their role as legal guardians and due to the limited cognitive capacity of young boys to fully comprehend fertility preservation counseling. Long-term follow-up is necessary to evaluate the impact on fertility outcomes, psychological well-being, and overall satisfaction. The aim of this survey is to assess the perceived impact of fertility preservation counseling and the physical and emotional effects of undergoing testicular biopsy in this population, with the goal of identifying opportunities to improve patient experience and clinical care for future patients.

Conditions

Satisfaction Survey; Fertility Perservation

Keywords

fertility preservation; boys; gonadotoxic treatment; male infertility; testicular tissue biopsy; spermatogonial stem cell; cryopreservation; long-term follow-up; survey

Outcome Measures

Primary Outcomes (1)

• The impact on quality of life of fertility preservation during childhood or adolescence.

  Assessment will be conducted by means of a confidential survey in \> 18 yo patients who have undergone in their childhood a fertility preservation. The number of patients who are eligible for the follow-up survey (n = 64) within the fertility preservation program of the CUSL is important compared to the overall number of boys who have participated in such a FP programme worldwide (n=1033) in 2023. Recipients' satisfaction level will be evaluated by both general and specific scores. The general satisfaction score is calculated by combining the responses to questions rating specifically recipients' satisfaction on specific items using a 5 elements Likert scale (Very Dissatisfied to Very Satisfied) and responses to closed questions which inquire participants' global satisfaction on specific subjects.

  From the start of the program in may 2005 and the last patient enrolled in may 2020

Study Arms (1)

Patients who underwent gonadotoxic treatment for oncological or benign disease

EXPERIMENTAL

This survey study aims to assess the long-term outcomes and patient satisfaction of men who underwent a fertility preservation procedure i.e., a testicular biopsy with cryopreservation of immature testicular tissue, during prepuberty or peripuberty at the Cliniques Universitaires Saint Luc (CUSL) since the start of the fertility preservation program in 2005. Participants will be asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received.

Other: Survey using a questionnaire.

Interventions

Survey using a questionnaire. OTHER

A monocentric experimental study conducted as a survey, including patients enrolled in our fertility preservation program between May 2005 and May 2020. Participants were asked about their current reproductive health status, their experience with the fertility preservation process, and their overall satisfaction with the care they received.

Patients who underwent gonadotoxic treatment for oncological or benign disease

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who have participated in the fertility preservation program aged 18 years old and above

You may not qualify if:

• Deceased patients. Patients undergoing treatment for disease relapse. Patients suffering from a documented mental disorder.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Cliniques universitaires Saint-Luc

Brussels, Belgium

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Christine Wyns, MD, PhD

  Cliniques universitaires Saint-Luc- Université Catholique de Louvain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: August 24, 2025
• Study Start: July 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 1, 2025
• Last Updated: August 24, 2025

Record last verified: 2025-07

Locations

BE (1)