Autologous Testicular Tissue Transplantation

Официальное название

Autologous Testicular Tissue Transplantation for Fertility Restoration

Обзор

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells in case of imminent gonadotoxic treatment during childhood. In case of total azoospermia or absence of spermatozoa that can be used for intra-cytoplasmic injection (ICSI) in adulthood, the investigators intend to perform the first in men autologous testicular tissue transplantation to restore fertility.

Подробное описание

Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. In 2002, the University hospital in Brussels (UZB) was the first hospital worldwide to offer testicular tissue cryobanking for fertility preservation in boys and ado-lescents. Since then, several other centers in Europe and USA have implemented similar fertility preservation programs. However, up till now, autologous transplantations of cryopreserved testicular tissue have not been performed yet.

As soon as a patient returns to the Centre for Reproductive Medicine at UZB with the request to transplant the preserved testicular tissue, the investigators will first analyse semen and blood. If spermatozoa are found in their semen, men can immediately enroll in standard care for natural conception, intra-uterine insemination (IUI), in-vitro fertilization (IVF) or intra-cytoplasmic injection (ICSI). However, if no spermatozoa suitable for ICSI are detected in the ejaculate, the investigators intend to propose and eventually perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Вмешательства

• Процедура Autologous testicular tissue transplantation of prepubertal frozen testicular tissue
  Freezing testicular tissue of prepubertal boys is a method for preserving spermatogonial stem cells. If no spermatozoa suitable for ICSI are detected in the ejaculate, the investigators will perform autologous testicular tissue transplantation with the primary objective being to restore spermatogenesis and fertility.

Первичные конечные точки

• Restoration of spermatogenesis and fertility by performing an autologous testicular tissue transplantation. Primary endpoint is the presence of spermatozoa in the graft. [Срок оценки: Graft-removal of intratesticular and intrascrotal grafts is planned 12 months after grafting.]

Вторичные конечные точки (5)

• Histological study to define the optimal transplantation site [Срок оценки: Graft-removal of intratesticular grafts and intrascrotal grafts are planned 12 months after initial grafting. Histological study will be performed 12 months after initial grafting]
• Imaging study [Срок оценки: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
• Endocrinological (hormonal) study [Срок оценки: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
• Biomarker Study [Срок оценки: Each patient in the study will be followed-up after screening during a period of 12 months post-grafting on 3, 6, 9 and 12 months after initial grafting.]
• Complications [Срок оценки: Each patient in the study will be follow-up after screening during a period of 15 months post-grafting.]

Критерии участия

The eligible patients opted as a prepubertal boy to enroll in the fertility preservation program and on the moment of cancer diagnosis or hematological disorder, their parents have agreed to cryopreserve testicular tissue for later autologous transplantation.

Критерии включения

• At least 18 years old
• In case of female partner, age < 43 year
• Absence of spermatozoa that can be used for ICSI on 2 semen analyses
• Normal standardised preliminary and preoperative bloodsampling results
• Complete remission of the oncological or hematological disease
• Approval of the treating oncologist or other specialist in case of non-oncological disease as reason for the testicular tissue preservation as a child
• Risk for presence of malignant cells in testicular tissue is negligible (according to multidisciplinary assessment)
• Presence of spermatogonial stem cells (positive MAGE staining) in one or two of the thawed fragments (If absence of spermatogonial stem cells in two of the thawed fragments, the case will be discussed multidisciplinary)
• Written informed consent for the transplantation of cryopreserved testicular tissue and follow-up after the procedure and of children born eventually after this procedure

Критерии исключения

• Risk for presence of malignant cells in the testicular tissue
• Contra-indication for surgery
• Contra-indication for pregnancy in the female partner
• BMI > 32
• Heavy smoking (≥10 cigarettes/day)
• Instable psychological condition

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• UZ Brussel Centre for Reproductive Medicine — Brussels

Идентификаторы

NCT: NCT05414045 · 2019-477

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗