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NCT Number: NCT04744519

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

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.

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Key information

Conditions

hCG

Age range

18 year–32 year

Sex eligibility

Female

Study type

Observational

Primary location

IVI Vigo

Vigo, Pontevedra, 36204, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Donors age < 32.
  • IMC< 30kg/m2.
  • Antral follicle count higher than 8.
  • Single Blastocyst transference.
  • 5% oxygen embryo culture,
  • time-lapse monitoring incubation KID embryos.

Exclusion criteria

  • 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.

Treatment and study plan

Collect data

Other
  • Controlled ovarian stimulation with GnRH antagonists effected to the patients in order to get their eggs through follicular puncture, which will be trigger by GnRH analogue. The eggs will be isolated and processed according to the standard protocol.

Other names: Collect retrospectively data on embryo implantation rate

Primary outcomes

  1. 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.

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

IVI Vigo

Other

Collaborators

  • Instituto Valenciano de Infertilidad, IVI VALENCIA

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Feb 9, 2021
Registry last updated
Feb 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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