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临床试验/NCT00977821
NCT00977821已完成4 期

Embryo Developmental Capacity After Egg Banking in an Ovum Donation Program

Instituto Valenciano de Infertilidad, IVI VALENCIA1 个研究点 分布在 1 个国家目标入组 625 人开始时间: 2009年9月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
625
试验地点
1
主要终点
Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.

研究概览

简要总结

For an efficient "egg banking" system, an equally efficient cryopreservation strategy that ensures the viability of the oocytes is required. Very recently, improved and new methods are yielding satisfactory results. In particular, vitrification is providing excellent results for both survival and clinical outcomes. However, to evaluate the over all out come there are other parameters to be considered. In this sense, capacity development of embryos generated after oocyte vitrification is a major factor when assessing the viability of vitrified oocytes. Accordingly, the evaluation of the capacity of vitrified oocytes to reach the blastocyst stage will be highly valuable to fully assess the effectiveness of the "egg banking" and its contribution to ovum donation programs.

The aim of this study is to evaluate the developmental capacity of vitrified oocytes by their ability to reach the blastocyst stage. The study includes oocyte donation cycles conducted with vitrified versus fresh oocytes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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
是

入选标准

  • •18-35 year old
  • •Normal response (8-15 follicles) to long protocol of ovarian stimulation with hCG
  • •Donors with normal menstrual cycles (21-35 day duration)
  • •Donors with BMI between 18-25 Kg/m2

排除标准

  • •Donors with two or more previous miscarriages
  • •Polycystic ovary syndrome
  • •Donors with antecedents of poor embrionary quality not attributed to masculine factor
  • •Donors with drop of estradiol of more than 10% or estradiol plateau.
  • •Donors with a high response>20 oocytes and or levels above 3000pg/ml of estradiol the day of the administration of chorionic gonadotrophin (hCG)

研究组 & 干预措施

fresh

Active Comparator

Embryo transfer with fresh oocytes

干预措施: IVF (Other)

Frozen

Experimental

Embryo transfer with vitrified oocytes

干预措施: Oocyte Vitrification (Other)

结局指标

主要结局

Mean outcome measures will be survival, fertilization and blastocyst rates and clinical outcome.

时间窗: 10 months

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
责任方
Principal Investigator
主要研究者

Carlos Simon

Dr. Carlos Simon MD PhD

Instituto Valenciano de Infertilidad, IVI VALENCIA

研究点 (1)

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