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临床试验/NCT06063551
NCT06063551招募中不适用

Cryopreservation of Prepubertal Testicular Tissue for Preservation

University of Edinburgh2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Reproductive hormones

研究概览

简要总结

Prepubertal boys treated for cancer are at risk of infertility as a result of their treatment. At present there are no options to preserve fertility in these boys. With informed consent, the investigators aim to cryopreserve (freeze) testis tissue biopsies taken from boys undergoing cancer therapy with a high risk of infertility. A portion of cryopreserved tissue will be securely stored, which in the future may be used to restore fertility in the patients. A second portion of the tissue will be used for laboratory work aimed at understanding the conditions required for development of the germ cells.

Patients will be recruited from the Oncology Department at the Royal Hospital for Children and Young People (RHCYP) in Edinburgh. Tissue will be obtained from prepubertal patients with cancer who are about to undergo treatment with a high risk (>80%) of infertility. Informed consent will be obtained from the patients legal guardian (and patient if applicable) for the procedure and subsequent use of tissue. A testis biopsy from one testis will be performed and if possible will coincide with a planned routine procedure requiring general anaesthetic in order to avoid the need for additional anaesthesia.

The procedure will take place at RHCYP during the initial assessment and prior to the commencement of cancer treatment and will not result in delay of treatment. Tissue will be assessed for the presence of sperm for storage using existing methods. In addition, tissue will be cryopreserved by Tissue and Cells Directorate, SNBTS in Edinburgh. The tissue will be stored for up to 55 years in accordance with current legislation (HFEA Act as amended 2005). Research will be carried out at the MRC Centre for Reproductive Health in accordance with Human Tissue (Scotland) Act 2006.

详细描述

Objectives

  1. Primary Objective

a) Cryopreservation of testicular tissue from pre- and peri-pubertal patients undergoing potentially sterilising therapy for future therapeutic use to preserve fertility.

i. Development/refinement of inclusion and exclusion criteria ii. Exploration of patients and parents attitudes to this approach to fertility preservation iii. Development of the required multidisciplinary group to provide this 2. Secondary Objectives

  1. Follow-up patients after testis tissue cryopreservation
  2. Laboratory research - testicular germ cell development for fertility preservation i. Development of optimal freezing methods for testicular tissue ii. In-vitro culture methods for germ cell maturation iii. Development of xenografting approaches for maturation of germ cells

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
1 Day 至 18 Years(Child, Adult)
性别
Male
接受健康志愿者

入选标准

  • Pre- and peripubertal boys
  • Due to receive cancer treatment that is predicted to have a high risk (>80%) of infertility
  • Consent to removal of testicular tissue for storage and research
  • Unable to produce a semen sample by masturbation

排除标准

  • Participation in study would delay treatment
  • Too unwell to undergo the procedure
  • Pre-existing testicular pathology/previous testicular surgery (eg orchidopexy)
  • Able to produce a semen sample for cryopreservation

结局指标

主要结局

Reproductive hormones

时间窗: On reaching adulthood, typically 18 years.

Measurement of reproductive hormones in blood

Assessment of fertility

时间窗: On reaching adulthood, typically 18 years.

Semen analysis for sperm count

次要结局

  • Germ Cell Development(2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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