The Clinical Outcome of Ultra-low Oxygen Tension on Post Thawed Human Blastocyst
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)
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)
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
Salma El Tanbouly
Senior Clinical Embryologist
Ganin Fertility Center
