A Study Select Top-grade Embryo by Time-lapse Imaging
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- live birth rate
研究概览
简要总结
To establish embryo time-difference kinetics scoring model for embryo selection before embryo transfer. It is especially suitable for selective single embryo transfer, advanced infertile women, and patients with repeated transplant failure. It can effectively improve clinical pregnancy rate, improve embryo implantation rate and Rate of return home. Reduce the risk of multiple pregnancies.
详细描述
- BACKGROUND:
At present, embryo selection in embryonic laboratories at various reproductive centers continues to follow conventional morphological assessments based on the time period provided by the 2016 Expert Consensus Guidelines for Laboratory Operations (revised from the Istanbul consensus) (discussion board), after insemination of the 1th-6th day (except the 4th day) to observe the specific time points of embryonic morphology, static observation, score, select the embryo. This method of observation of embryonic development is not comprehensive enough, and the lack of quantifiable recognized indicators .
EmbryoScope Time-lapse culture system is the latest development of human assisted reproductive embryo from fertilization to blastocyst development. The time-lapse imaging system (TLI) is used to record the embryonic development process from fertilization to blastocyst formation. The timing of change plays a key role in the developmental potential of the embryo, such as the time of emergence and disappearance of pronucleus, the time of early cleavage, cleavage pattern and so on. At present, the latest 2016 Laboratory Operation Expert Consensus Guide (discussion board) provides a grading standard that does not objectively reflect specific information on morphological changes, such as cleavage patterns, the specific time of morphological changes, and so on for embryonic development and post- Determine the fate of embryos play a vital role. Due to the clinical diagnosis and treatment of the center of the standard, laboratory culture system, and the difference between the laboratory standard operation procedure,and embryonic development speed differences. Therefore, it is desirable to use the EmbryoScope Time-lapse culture system to find out the best timing of morphological changes of embryos in accordance with the laboratory culture system on the basis of the expert consensus time period. To establish an evaluation model of embryo morphology kinetics suitable for our laboratory. Embryology time-of-flight monitoring Morphological kinetics evaluation model is suitable for patients with in vitro fertilization/ intracytoplasmic sperm injection , especially for infertile women in assisted reproduction, women with repeated transplantation failure, women with fertility disorders requiring egg activation, Single embryo transfer of patients, effectively avoid multiple pregnancy, reduce the risk of multiple pregnancy. Selection of embryos with developmental potential for transplantation, improve embryo quality, improve the accuracy of embryo selection, contribute to successful pregnancy. But also can alleviate this part of the patient's mental stress, but also contribute to successful pregnancy. At the same time, for laboratory embryologists to provide more data reference, more human embryonic development information.
At present, several large-scale centers are undergoing their own embryo laboratory kinetics of the scoring model. Shanshan Wang et al suggested that the cleavage pattern of embryos and time parameters combined to establish a new embryo screening model for single embryo transfer embryo, to obtain an ideal pregnancy outcome.
EmbryoScope Time-lapse culture system and embryo selection, compared to the traditional culture system and the static morphology of the embryo selection, EmbryoScope Timelapse selection of transplanted embryos, the clinical pregnancy rate [3], EmbryoScope Time-lapse culture system, Significantly improved. The literature of N. Basile and P. Vime [4] suggests that blastocyst culture [10] plus the choice of embryo morphology kinetics may be the best treatment for improving clinical outcomes. Studies have been reported , time difference imaging system does not interfere with embryonic culture conditions in the case of interval 20 min, 5 min or 1 min to shoot images, and continued to the first 3 days or 5 days. In addition, the TLI image acquisition system can exclude some of the abnormal cleaved embryos that are considered to have "normal" developmental potential in static assessment. A number of studies have shown that the TLI culture system combined with the morphological scoring method to select the embryos obtained after transplantation compared with the purely morphological method of the choice of static embryos can be more satisfactory to patients with pregnancy outcomes .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- — 至 38 Years(Child, Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women under 38 years of age
- •transplantation cycle
排除标准
- •women with abnormal oocytes in the past(≥30%)
- •women with other systemic diseases
- •women with abnormal uterine cavity shown on hysterosalpingogram or saline infusion sonogram
结局指标
主要结局
live birth rate
时间窗: 1 year
numer of live birth per transfer cycle
次要结局
- clinical pregnancy rate(1year)
- implantation rate(1year)
