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临床试验/NCT03128580
NCT03128580终止不适用

Embryo Aneuploidies and Morphokinetics in Ovarian Stimulated and Non Stimulated Cycles. An Intrapatient Comparison Using Next Generation Sequencing in Biopsy of Blastocysts and Time Lapse Evaluation.

Instituto Valenciano de Infertilidad, IVI VALENCIA2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2017年4月21日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
40
试验地点
2
主要终点
Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.

研究概览

简要总结

The purpose of this study is to compare the number of euploid embryos obtained per metaphase II oocyte in unstimulated (modified natural cycles) and stimulated IVF cycles.

详细描述

Effects of ovarian stimulation on human embryo quality is still a subject of study. When natural and stimulated cycles have been compared, no differences have been observed in terms of embryo cleavage capacity, oocyte and embryo aneuploidy rate or incidence of aneuploidy in aborted foetuses. When mild and conventional doses of gonadotropins have been compared, a higher proportion of good morphological quality embryos are observed in the former. On the contrary, we showed that ovarian stimulation does not increase significantly the embryo aneuploidy rate in IVF derived human embryos when unstimulated and stimulated cycles were compared in oocyte donors. In this study, we want to compare the embryo aneuploidy rate between unstimulated and stimulated cycles in infertile patients, subjected to both IVF cycles with blastocyst biopsy and NGS-PGS. A comparison of the morphokinetics will also be performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
30 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 30-38 years old (inclusive)
  • with regular menstrual cycles (25-35 days)
  • AntiMülleriana Hormone >5 pmol/L.
  • Undergoing IVF treatment

排除标准

  • BMI >30 kg/m2
  • repeated miscarriages
  • implantation failure
  • uterine or adnexal pathology
  • Unable to be treated with gonadotrophins for the ovarian hyperstimulation
  • history of low response to ovarian hyperstimulation
  • participation in another study with PGS for monogenic pathology
  • Cryptozoospermia in male partner

结局指标

主要结局

Comparison of the number of euploid embryos from Metaphase II oocytes in different cohorts of embryos.

时间窗: 30 days

Number of metaphase II oocyte per euploid embryo in unstimulated and stimulated cycles.

次要结局

  • Incidence of embryo aneuploidies in two cohorts of embryos.(30 days)
  • Morphokinetic evaluation of embryos in two different cohorts of embryos.(30 days)

研究者

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

研究点 (2)

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