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临床试验/NCT07140549
NCT07140549Enrolling By Invitation不适用

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

Cliniques universitaires Saint-Luc- Université Catholique de Louvain1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
60
试验地点
1
主要终点
The impact on quality of life of fertility preservation during childhood or adolescence.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
申办方类型
Other
责任方
Sponsor

研究点 (1)

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