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临床试验/NCT01422395
NCT01422395已完成早期 1 期

A Study to Compare Vitrified/Warmed Oocytes vs. Fresh Sibling Oocytes Collected Following Controlled Ovarian Stimulation Using Follistim AQ and Ganirelix Acetate on Fertilization Rates, Zygote Quality, Embryo Quality and Embryo Development

Main Line Fertility Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2011年8月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
fertilization rate

研究概览

简要总结

Indications for oocyte (egg) vitrification (fast freezing) include the preservation of reproductive competence of young cancer patients who need chemotherapy, pelvic radiation, or surgical removal of ovaries for treatment. Furthermore, the ability to freeze oocytes allows patients to reduce the number of embryos frozen, thereby circumventing the moral and ethical dilemmas of having left-over embryos in cryostorage. In addition, oocyte cryopreservation could allow women to delay childbearing if they want or need to. Until recently, conventional cryopreservation protocols have remained too inefficient for practical application in an infertility center. Very little is known about the effects of vitrification on oocytes and subsequent embryo development, especially using the sibling model (group of oocytes from the same cohort of ovarian follicles within patient). The purpose of this study is to examine the effect of oocyte vitrification on fertilization rates, embryo quality and development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Investigator)

入排标准

年龄范围
21 Years 至 37 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • healthy women ages 21-37 (inclusive)undergoing IVF in an attempt to achieve pregnancy
  • Day 2-4 FSH < 10 IU/ml, LH <12 IU/ml, and E2 <50 pg/ml
  • Antimullerian Hormone (AMH) >1.5
  • Between 5 and 20 basal antral follicles on day 2-4 of the menstrual cycle
  • BMI >18 and <32

排除标准

  • Polycystic Ovarian Syndrome (PCO)

结局指标

主要结局

fertilization rate

时间窗: 18 hours after insemination

Embryo Quality

时间窗: day 3 and day 5

Embryo Development

时间窗: Day 3 and day 5

次要结局

未报告次要终点

研究者

发起方
Main Line Fertility Center
申办方类型
Other
责任方
Sponsor

研究点 (2)

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