Ovarian Rejuvenation: Regeneration of Ovarian Follicles in Women With Poor Ovarian Reserve by Autologous Transplantation of Bone Marrow Derived Progenitors Cells in Peripheral Blood. Pilot Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Ovarian reserve
研究概览
简要总结
Women delay maternity and, as a consequence, available oocyte number and their quality decrease (9-18% of all IVF patients). Different treatment protocols have been developed nevertheless none of them optimal: the number of oocytes retrieved depends on the present ones. New generation of oocytes and follicles has been defended by some authors and bone marrow seems to be involved. What seems crucial is the niche that produces paracrine signals able to activate dormant cells and to attract undifferentiated cells from other tissues (homing). This phenomenon has been described by our group in other human reproductive tissues like endometrium. The purpose of the study is to improve ovarian reserve in unfertile women with poor ovarian reserve by means of bone marrow protective capacity.
Bone marrow progenitor cells will be delivered into the ovarian artery allowing them to colonize ovarian niche.
The study hypothesis is that bone marrow progenitor cells will improve ovarian reserve differentiating themselves into germ cells or, more likely, stimulating the niche to activate dormant follicles.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •< or= 40 years old
- •FSH<15UI/L
- •poor ovarian response after controlled ovarian stimulation with conventional doses (<3 oocytes) or two episodes of poor ovarian response after ovarian stimulation with maximal doses even if young or normal ovarian reserve study.
- •Antral follicle count>2
- •>1 antral follicle in the perfused ovary
- •AMH between 0,5 and 3pmol/L
- •regular menstrual bleeding each 21-35 days
- •To be candidate to autologous hematopoietic progenitors transplantation
排除标准
- 未提供
研究组 & 干预措施
Poor ovarian reserve women
干预措施: Bone marrow transplant into ovarian artery (Drug)
结局指标
主要结局
Ovarian reserve
时间窗: 6 months
Measured by FSH-LH, oestradiol, AMH, antral follicle count
次要结局
- Ovarian response to controlled ovarian stimulation(6 months)
研究者
Dr. Antonio Pellicer Martínez
Professor
Hospital Universitario La Fe
