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临床试验/NCT00802295
NCT00802295已完成不适用

Influence of Ovarian Stimulation and Embryo Aneuploidy

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年12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
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Aneuploidy rate with two different stimulation protocols.

研究概览

简要总结

Our working hypothesis is that patients undergoing "in vitro" fertilization (IVF) with higher response to ovarian stimulation protocols recover a higher number of oocytes and, this elevated response could be translated into increased incidence of chromosomally abnormal embryos. Our objective is to develop a prospective study on healthy young donors, with a previous cycle with high ovarian response (>20 oocytes and/or E2 levels the day of the hCG injection >3000 pg/mL), but without developing mild or severe hyperstimulation syndrome. After signing a proper written consent, these donors would agree to undergo two subsequent stimulation cycles following two different protocols. In one cycle the stimulation pattern would be similar to the previous one, with elevated response and, in another cycle the amount of gonadotropins would be cut down in order to obtain lower ovarian response. Oocytes obtained in each cycle would be donated to anonymous recipients and after fertilization, embryo quality and chromosomal status of the resulting embryos would be evaluated. Preimplantation genetic diagnosis (PGD) will be performed on day-3 embryos and chromosomes 13, 15, 16, 17, 18, 21, 22, X and Y would be analyzed by fluorescence "in situ" hybridization (FISH).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 29 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Healthy women between 18 - 29
  • with previous cycle with standard dosis of Gonadotrophin and high response to the treatment (> 20 oocytes)
  • No symptom of OHSS

排除标准

  • donors with 2 previous miscarriages
  • Severe Male Factor

研究组 & 干预措施

standard dosis protocol

Active Comparator

Administration of standard dosis of gonadotrophins for ovarian stimulation.

干预措施: Gonadotrophins (Drug)

2

Experimental

Administration of low dosis of Gonadotrophins for ovarian stimulation

干预措施: Low dosis Gonadotrophin (Drug)

结局指标

主要结局

Aneuploidy rate with two different stimulation protocols.

时间窗: three months

次要结局

  • Normal blastocyst rate(three months)

研究者

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

研究点 (1)

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