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临床试验/NCT04342364
NCT04342364已完成不适用

Oocyte Survival After Vitrification With Slush Nitrogen Compared With Liquid Nitrogen

Reproductive Medicine Associates of New Jersey2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
oocyte survival rate

研究概览

简要总结

The purpose of this study is to determine if the use of slush nitrogen results in higher post-thaw survival rates for oocytes compared to conventionally used liquid nitrogen.

详细描述

The study is a randomized, controlled trial which seeks to characterize oocyte survival rate following vitrification and subsequent warming with both slush nitrogen and liquid nitrogen. After warming, fertilization and embryology outcomes will be assessed.

Oocyte donors and a single donor sperm source will be utilized. Following enrollment, oocyte donors will undergo ovarian stimulation and oocyte retrieval. The mature (MII) oocytes obtained for each patient will then be assigned a number and randomized via block randomization to one of two treatment groups (liquid nitogen or slush nitrogen). Through block randomization, this will create a paired population of oocytes so that half of each patient's oocytes will undergo cryopreservation with liquid nitrogen and half will undergo cryopreservation with slush nitrogen. Timing of hyaluronidase stripping and vitrification will be consistent with current institutional clinical practice for oocytes.

Following cryopreservation, oocytes will be warmed and intracytoplasmic sperm injection will be performed and subsequent embryology outcomes tracked.

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 (Outcomes Assessor)

盲法说明

embryologist assessing oocyte survival (primary outcome) is blinded

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

oocyte survival rate

时间窗: within 5 minutes post warming

number of viable oocytes post warming

次要结局

  • euploid rate(1 week after trophectoderm biopsy)
  • fertilization rate(18 hours post injection)
  • blastulation rate(4-6 days after fertilization)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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