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OpenTrials
Enrolling by Invitation

NCT Number: NCT07140549

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

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.

Enrolling by Invitation

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques universitaires Saint-Luc

Brussels, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Registry information

Official study title

Survey of Patients Who Underwent Testicular Tissue Cryopreservation for Fertility Preservation Prior to Gonadotoxic Therapy in Childhood or Peripuberty

Acronym: QUALIFERT

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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