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临床试验/NCT04744519
NCT04744519已完成不适用

hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy

IVI Vigo1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年1月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
300
试验地点
1
主要终点
Researchers pretend to correlate the quality of the trophoectoderm and the embryo morphokinetics time with the hCG concentration after 13 days of embryo transfer, and also the implantation and the ongoing pregnancy rate.

研究概览

简要总结

hCG is a hormone produced very early by the 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 retrospective study is to evaluate the relationship between the hCG concentration in peripheral maternal blood measured 11 days after embryo transfer, embryo morphokinetics pattern and the abortion and ongoing pregnancy rates.

We will study patients having transference of blastocyst cultured in time lapse monitored incubators and will check all the morphokinetics parameters with the IVI database.

详细描述

Human chorionic gonadotrophin is a two subunits (alpha and beta) glycoprotein hormone secreted by blastocyst trophoblastic cells.

It plays a role in progesterone secretion by corpus luteum, endometrium invasion and fusion by trophoectoderm, angiogenesis, and induction of trophoblast differentiation Shortly after embryo implantation, trophoblastic hCG is detectable in maternal blood, and its concetration depends on the number and functionality of trophoectoderm cells. Therefore, hCG concentration in maternal blood is measured as an early pregnancy marker.

However, hCG concentration in several women showed high variability, and embryo implantation also depends on endometrial receptivity, what means that in early stages, everything affecting endometrial receptivity, may affect hCG concentration.

Early high hCG concentration has been related with higher pregnancy rate and it has been proposed that hCG concentration may be related to the time of embryo implantation and the viable trophoectoderm cell number.

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 32 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Donors age <
  • IMC< 30kg/m
  • Antral follicle count higher than
  • Single Blastocyst transference.
  • 5% oxygen embryo culture,
  • time-lapse monitoring incubation KID embryos.

排除标准

  • Müllerian anomalies,
  • Hydrosalpinx.
  • Any indication of oocyte vitrification.
  • Severe male factor.
  • Embryos transferences where a tenaculum was required, or more than one attempt was needed.

结局指标

主要结局

Researchers pretend to correlate the quality of the trophoectoderm and the embryo morphokinetics time with the hCG concentration after 13 days of embryo transfer, and also the implantation and the ongoing pregnancy rate.

时间窗: Since 2013 to april 2019

• Clinical pregnancy: when the maternal serum levels of β-hCG are higher than 10 UI/L, between 14 and 16 days after the fertilization and the presence of a gestational sac can be appreciated by ultrasound scan a week later (21-23 days after fertilization)

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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