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临床试验/NCT01966536
NCT01966536撤回不适用

CD133+ Autologue Transplantation to Promote Ovarian Follicles Development in Women With Poor Ovarian Reserve.

Hospital Universitario La Fe2 个研究点 分布在 1 个国家开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
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 developped 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.

CD133+ cells obtained from bone marrow will be delivered into the ovarian artery allowing them to colonize ovarian niche.

The study hypothesis is that CD133+ 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 perfunded ovary
  • AMH between 0,5 and 1pmol/L
  • regular menstrual bleeding each 21-35 days
  • To be candidate to autologous hematopoietic progenitors transplantation

排除标准

  • Ovarian endometriosis
  • Anovulation
  • Any ovarian surgery considered risk factor of low ovarian response.
  • Genetic factors associated to low ovarian response (Turner syndrome, FMR1 mutations...)
  • Adquired conditions determining low response (chemotherapy, radiotherapy...)
  • BMI > or = 30kg/m2
  • Allergie to iodine
  • Kidney failure

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 stimulation for oocyte retrieval(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

Doctor

Hospital Universitario La Fe

研究点 (2)

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