Influence of Ovarian Stimulation and Embryo Aneuploidy
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
- 是
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
Administration of standard dosis of gonadotrophins for ovarian stimulation.
干预措施: Gonadotrophins (Drug)
2
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)
