跳至主要内容
临床试验/NCT00785993
NCT00785993已完成4 期

Impact of Egg-Banking in an Ovum-donation Program

Instituto Valenciano de Infertilidad, IVI VALENCIA2 个研究点 分布在 1 个国家目标入组 320 人开始时间: 2008年11月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
320
试验地点
2
主要终点
To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.

研究概览

简要总结

Egg-banking would considerably simplify the logistics and means by which oocytes could be donated. These banks would make it easier to immediately provide oocytes that would be compatible to the recipient, shortening or even eliminating the problem of long waiting lists. Egg-banking would also allow the oocytes to be effectively quarantined, drastically diminishing the risk of transmission of infectious diseases in a fashion analogous to semen banks. The most essential prerequisite for a successful egg cryo-banking program is to have an efficient oocyte cryopreservation technology. Recent studies, including our own experience, have indicated that vitrified oocytes preserve intact their potential to fertilize and further develop into competent embryos, giving high clinical results as well as high survival rates. The aim of this study is to evaluate impact of the establishment of an egg-banking in our ovum donation program. Oocyte cryopreservation is carried out by Cryotop method. The study includes oocyte donation cycles conducted with fresh and vitrified oocytes. Recipients are allocated randomly into each group ("fresh vs. vitrified cycles"). Main outcome measures include survival, fertilization, embryo development and clinical outcome.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Receptors
  • Women receiving donor oocytes and whose partners without seere pathology of semen.
  • BMI < 25
  • Inclusion Criteria:
  • 18 - 35 years oldaños.
  • Normal Response (8-15 follicles)to long protocol of ovarian stimulation with hCG
  • Donors with normal menstrual cycles ( 21-35 day duration).
  • Donors with Body Mass Index (BMI) between 18-25 Kg/m2

排除标准

  • Donors with +/= two previous miscarriages'
  • Polycystic Ovary Syndrome
  • Donors with antecedents of poor embrionary quality not attributed to masculine factor.
  • Donors with decline of Estradiol Hormone of more than 10% or Estradiol Hormone plateau.
  • Donors with a high response >20 ovocitos and/or levels above 3000pg/mL of Estradiol the day of the administration of Chorionic gonadotropin (hCG.

结局指标

主要结局

To evaluate the clinical outcome in an ovum donation program conducted with egg-banking.

时间窗: 14 days

次要结局

未报告次要终点

研究者

发起方
Instituto Valenciano de Infertilidad, IVI VALENCIA
申办方类型
Other

研究点 (2)

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