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临床试验/NCT02240342
NCT02240342Unknown不适用

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.

Hospital Universitario La Fe1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Antonio Pellicer Martínez

Professor

Hospital Universitario La Fe

研究点 (1)

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