Fertility Restoration With Autotransplantation of Cryopreserved Immature Testicular Tissue (ITT) Restaurer la fertilité à Partir de Tissu Testiculaire Immature (TTI) cryopréservé Par Auto-transplantation du Tissu
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of graft function
研究概览
简要总结
This is a pilot clinical trial to evaluate the feasibility and outcome of autologous transplantation of immature testicular tissue cryopreserved during childhood as a method of fertility preservation for prepubertal boys in case of gonadotoxic therapies.
Freezing of immature testicular tissue is performed since the early 2000s and a number of our patients have now reached reproductive age. In case of childwish and azoospermia in adulthood, surgical sperm retrieval is planned and if unsucessful transplantation of the patient's own cryopreserved tissue will be performed during the same surgical intervention as a fertility restoration method.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •all are required
- •patients who have completed their gonadotoxic treatment
- •patients who are in good health after care of the primary disease based on hemato-oncologist input
- •patients with proven azoospermia in adulthood and child's wish requesting transplantation
- •patients who cryopreserved and stored their immature testicular tissue (in conformity with regulatory requirements)
- •in case of prior hematological malignant disease or metatstatic cancer, if the multidisciplinary assesment considers the risk of cancer cell contamination is negligible
排除标准
- •patients for whom the cryostored tissue presents a non-negligible risk of cancer cells contamination
- •patients presenting with a contraindication for general anethesia
研究组 & 干预措施
Autologous transplantation of cryopreserved immature testicular tissue in azoospermic adults
Avascular transplantation of own testicular tissue pieces cryopreserved during childhood will be performed during a surgical sperm retrieval procedure when no sperm is found.
干预措施: autologous transplantation of cryopreserved testicular tissue (Procedure)
结局指标
主要结局
Assessment of graft function
时间窗: Assessments of hormones and growth of the graft will be performed at 1 month (M), 3 M, 6M, 12M, 24 M after grafting/transplantation procedure. Presence of sperm will be performed at graft recovery (immediately during surgery on fresh and fixed samples).
Blood sampling for hormones and growth of the graft as visulalized by ultrasound will be performed during follow-up. Presence of sperm will be evaluated at the recovery of the graft.
次要结局
- Assesment of conception potential of sperm recovered in grafts and used in ART(HCGb in blood at Day 15 (+-1 Day) post-ICSI and if positive confirmed after 48 Hours (+-24 Hours). Ultrasound 15 Days +-7 Days after ICSI.)