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临床试验/NCT02778217
NCT02778217Unknown不适用

The Blastocyst Development and Clinical Outcome in Single Step Medium With or Without Renewal on Day 3 in a Time-lapse Incubator

Dar AlMaraa Center1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
Clinical pregnancy rate

研究概览

简要总结

Culture media used to support development of zygotes to the blastocyst stage is based on two basic philosophies: a single step medium "let-the-embryo-choose" or a sequential medium "back-to-nature".

For single step media, there are two types of protocol can be used for the culture of human preimplantation embryos:

  1. Interrupted single medium culture, in which the medium is renewed on the Day 3 of embryo culture
  2. Uninterrupted single embryo culture, in which the same single medium is used throughout the 5-6 days of culture with no replenishment or replacement on Day 3.

Investigators aim to compare the blastocyst development and clinical outcome between the two types of protocols of a single medium (with or without renewal on Day 3)

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者
否

入选标准

  • •female partners were under the age of 39 years
  • •Intracytoplasmic sperm injection (ICSI) was performed using fresh ejaculates

排除标准

  • •Day 3 embryo transfer cycles

研究组 & 干预措施

Uninterrupted single embryo culture

No Intervention

The same single medium is used throughout the 5-6 days of culture with no replenishment on day 3.

Interrupted single medium culture

Experimental

The single step medium is renewed on Day 3 of embryo culture.

干预措施: Culture media renwal (Procedure)

结局指标

主要结局

Clinical pregnancy rate

时间窗: 4 weeks post embryo transfer

diagnosed by the presence of a heartbeat in the gestational sac visualized by ultrasound

次要结局

  • Blastocyst formation rate(5-6 days post intracytoplasmic sperm injection)
  • Implantation rate(4-6 weeks post embryo transfer)

研究者

发起方
Dar AlMaraa Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yasmin

Senior clinical embryologist

Dar AlMaraa Center

研究点 (1)

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