Survey of Patients Who Underwent Testicular Tissue Cryopreservation for Fertility Preservation Prior to Gonadotoxic Therapy in Childhood or Peripuberty
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- The impact on quality of life of fertility preservation during childhood or adolescence.
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients who have participated in the fertility preservation program aged 18 years old and above
Exclusion Criteria
- •Deceased patients. Patients undergoing treatment for disease relapse. Patients suffering from a documented mental disorder.
Outcomes
Primary Outcomes
The impact on quality of life of fertility preservation during childhood or adolescence.
Time Frame: From the start of the program in may 2005 and the last patient enrolled in may 2020
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.
Secondary Outcomes
No secondary outcomes reported