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临床试验/NCT04736160
NCT04736160Unknown不适用

Pilot Study: hCG Secreted by Blastocyst as Potential Marker of Embryo Quality

IVI Vigo1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年12月5日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
To evaluate the relation between the amount of hCG secreted by blastocyst and morphological embryo quality according to morphokinetic pattern.

研究概览

简要总结

hCG is a hormone produced very early by the pre-embryo, but not by the oocyte. It has a pivotal role in the trophoblast differentiation, and embryo implantation as well as the corpus luteum support. In spite of its well-known role, the literature about it is scarce.

The aim of this study is to evaluate the relation between the amount of hCG secreted by the blastocyst and embryo euploidy status and morphological pre-embryo quality according to morphokinetic pattern.

We will analyse the amount of hCG secreted by blastocyst to the culture medium thorough mass spectrometry and it will be correlated with the main morphokinetic issues and the chromosomal structure after NGS analysis at blastocyst stage.

We will take the pre-embryo spent culture medium that has been discarded after embryo culture without any interference on the pre-embryo neither any different deviation of standard protocol of embryo manipulation. Furthermore, the evaluation by time-lapse technology will let to document the main issues of embryo development, also without any deviation of the standard protocol.

We are waiting to find the value of hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.

详细描述

Embryo selection based on morphological and morphokinetic characteristics seems to be insufficient to guarantee implantation. For this reason, in recent years, it has appeared new embryo selection strategies to increase the success of assisted reproduction treatments.

Human chorionic gonadotrophin (hCG) is a glycoprotein hormone composed of two subunits, alpha and beta, non-covalently attached. It is secreted by the blastocyst trophoblastic cells and because it is detectable in maternal blood shortly after embryo implantation and it can be used as a pregnancy marker (Cole et al., 1987).

Historically, it has been believed that the only function of hCG was to stimulate the secretion of progesterone by the corpus luteum. Nowadays, we know that it also plays a key role in the invasion, fusion of the endometrium by the blastocyst and the angiogenesis. In addition, it has a paracrine role to induce trophoblast differentiation (Cole, 2009).

Recently, it has been proposed that its concentration would be linked to the time after implantation and to the number of trophoblastic cells (Tanbo and Eskild, 2015). However, the concentration of hCG shows considerable variations among embryos, and it has been postulated that this could be due to differences in the implantation potential at the second week of embryo development (Lopata and Oliva, 1993). Then, hCG could be a good marker in embryo selection. In fact, it is already known that there is a higher secretion of hCG by those blastocysts that present more adherence to the culture plate compare with those that do not present it (Dokras et al., 1991).

In addition, this hormone presents variants that change as the blastocyst grows. The early embryos secreted more acidic variants than the more advanced ones (Lopata, 1997), and it has recently been shown that the different isoforms correspond to different degrees of glycosylation and metabolic degradation. The measurement of the concentration of these isoforms can be indicate to predict embryo implantation (Butler et al., 2013).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 41 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Hydrosalpinx.
  • Any indication of oocyte vitrification

结局指标

主要结局

To evaluate the relation between the amount of hCG secreted by blastocyst and morphological embryo quality according to morphokinetic pattern.

时间窗: Since 2018 to april 2020

hCG secreted by blastocyst as a potential marker of embryo quality and ploidy status.

次要结局

未报告次要终点

研究者

发起方
IVI Vigo
申办方类型
Other
责任方
Sponsor

研究点 (1)

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