跳至主要内容
临床试验/NCT03817671
NCT03817671Unknown不适用

The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst

Ganin Fertility Center1 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2018年11月20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
168
试验地点
1
主要终点
Clinical Pregnancy rate

研究概览

简要总结

The clinical outcome of Ultra-low oxygen tension on post thawed human blastocyst

详细描述

In vitro, Embryo development depends on several factors as temperature, pH, and oxygen in the surrounding environment of the embryo. Impaired culture conditions are highly correlated with poor embryo development. Oxygen is a powerful regulator of embryo function , as it is responsible for cell respiration, energy production and rapid cell growth . Increased levels of oxygen is associated with an increase in the levels of ROS , which leads to unfavorable culture conditions, as it might affect the stability of cell membrane, DNA, and protein function .

In the female reproductive tract, oxygen concentration fluctuates between 2-8%, which is considered to be at its highest level in the fallopian tube, while the lowest level is in the uterus . Pre-implantation embryo crosses the uterotubal junction after the time of compaction on Day 3, where it is exposed to a shift in oxygen tension to 2%. This variation may have a role in the metabolic reactions of the embryo, and in its preparation for implantation process.

Some studies suggested that culturing embryos with oxygen tension below 5% may have an embryological advantage mimicking nature.

Embryological laboratories routinely use low Oxygen tension (5%). Our purpose is to investigate if ultra-low oxygen tension (2%) has an advantage over low oxygen tension (5%) for post thawed human embryo regarding clinical outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
5 Days 至 6 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Single or Multiple Embryo transfer embryo transfer. Female age 18-
  • •Embryo vitrified on day 5 or day 6 of insemination.

排除标准

  • •Use of sperm donation. Use of Oocyte donation. Use of gestational carrier. Uterine congenital anomalies. Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previously known uterine infection.
  • •Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation.

研究组 & 干预措施

Control arm (5% O2)

Other

After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 5% O2, and 89.3% N2 till embryo transfer

干预措施: 5% O2 (Other)

Experimental arm (2%O2)

Experimental

After thawing, embryos will be cultured in 25 μl drop of pre-equilibrated dishes of media covered with a layer of oil for 1.5 hours at 5.7% CO2, 2% O2, and 92.3% N2 till embryo transfer

干预措施: 2% O2 (Other)

结局指标

主要结局

Clinical Pregnancy rate

时间窗: Time frame: 15 days following embryo transfer

Defined as the pregnancy that is confirmed by both high levels of hCG and ultrasound confirmation of a gestational sac or heartbeat

次要结局

  • Ongoing pregnancy rate(Time frame: 20 weeks of gestation)

研究者

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

Salma El Tanbouly

Senior Clinical Embryologist

Ganin Fertility Center

研究点 (1)

Loading locations...

相似试验

The Clinical Outcome of Ultra-low Oxygen Tension on... | 临床试验