Autograft of Human Ovarian Tissue: Efficiency and Safety Evaluation
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
研究概览
简要总结
Ovarian tissue cryopreservation is a new technique for female fertility preservation. One way to restore fertility is autotransplantation of ovarian tissue.
The principal purpose of this study will be to evaluate the efficiency and safety of this procedure.
详细描述
Ovarian tissue cryopreservation is a new technique for female fertility preservation before gonadotoxic treatments. The first ovarian tissue cryopreservations were performed 10 years ago. There are two main methods to use frozen ovarian cortex: autograft of ovarian fragments and in vitro follicular growth. At the present time, none mature oocytes were obtained after culture. Since 2000, around twenty publications stating autografts of ovarian cortex reported 8 pregnancy and 6 life birth of healthy babies.
Since 1998 until 2008, in the unit of reproduction biology of pitie-salpetriere hospital in Paris, France, 330 patients have had an ovarian tissue cryopreservation for fertility preservation before gonadotoxic treatment. Among them, at the present time, 180 have a procreative age and in consequence, could ask for the use of their ovarian cortex.
The general aim of this protocol will be to propose to women wishing to have a baby, an ovarian tissue transplantation if the patients have an premature ovarian failure.
The principal aim of this study will be to evaluate the efficiency and the safety of ovarian transplantation.
Before grafting, the absence of contra- indication will be check. An informed consent will be signed by the patient. Autograft of ovarian cortex will be performed either in orthotopic or in heterotopic localization according to the pathology and a possible contra-indication to orthotopic position.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
1- orthotopic graft
干预措施: orthotopic graft (Procedure)
2- heterotopic graft
干预措施: heterotopic graft (Procedure)
结局指标
主要结局
Radiological (ultrasonography and MRI) changes in ovarian imaging from graft until the revovery of ovarian function
时间窗: every month after graft, up to 18 months
Radiological (only ultrasonography the first 3 months and after ultrasonography and MRI) follow up every month after graft until the recovery of ovarian function, up to 18 months
Biological (FSH, LH, E2 and AMH) changes from graft until the revovery of ovarian function
时间窗: every month after graft, up to 18 months
FSH, LH, E2 and AMH follow up every month after graft until the recovery of ovarian function, up to 18 months
次要结局
- Graft vascularization(every month up to 18 months)
- Relapse of the pathology(every month up to 18 months)
- Number of ovarian fragments necessary for ovarian function recovery(up to 18 months)
- Delay and quality of the ovarian function recovery between ortho and heterotopic graft(after ovarian function recovery, up to 18 months)