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临床试验/NCT03660904
NCT03660904已完成2 期

A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation

Benha University0 个研究点目标入组 74 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
74
主要终点
blastocyst immediate survival

研究概览

简要总结

This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).

详细描述

Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.

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
Double (Care Provider, Investigator)

盲法说明

only the investigator knew the procedure and the media provided for each case

入排标准

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

入选标准

  • age of the patients 22-37
  • All vitrified & thawed blastocyst.
  • unexplained cases or ovarian factors for infertility.

排除标准

  • extremes of age
  • cases of uterine factor
  • endometriosis

研究组 & 干预措施

Home made media

Experimental

home made vitrification & thawing kit

干预措施: home made vitrification & thawing kit (Biological)

Commercial media

Active Comparator

commercially available vitrification & thawing kit

干预措施: commercially made vitrification & thawing kit (Biological)

结局指标

主要结局

blastocyst immediate survival

时间窗: 0 hour at time of thawing

The effect of Vitrification protocol on the blastocyst immediate survival

次要结局

  • live birth rate(9 months)
  • Blastocyst survival at 6 hours(6 hours after thawing)
  • pregnancy rate(2 weeks after transfer)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahmed Saad

Assistant professor of Ob. & Gyn.

Benha University

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