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Status unknownNCT04736160Updated Feb 4, 2021

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

An observational study in Embryo Disorder, sponsored by IVI Vigo. Status unknown at 1 site in Spain. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2021-02-04.

Sponsored by IVI Vigo · Observational

The sponsor has not verified this record recently (last verified Jan 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
60
Ages
18 Years to 41 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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).

Despite all this, there are few studies published that measure the concentration of hCG in the culture medium and most of them are published more than 15 years ago (Hay and Lopata, 1988; Lopata and Hay, 1989; Dokras et al., 1991; Lopata and Oliva 1993). This fact, together with the need to optimize the embryo classification, makes us consider whether it could be a good candidate as an embryo/aneuploidy selection marker.

02

Conditions studied

  • Embryo Disorder
03

Who can participate

Ages eligible
18 Years to 41 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients undergoing IVF with indication of PGT-A and time-lapse evaluation

Inclusion criteria

  • Age \< 42.
  • BMI \< 30kg/m2.
  • SET (Single embryo transfer)

Exclusion criteria

Exclusion Criteria:

  • Hydrosalpinx.
  • Any indication of oocyte vitrification
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
60 participants (estimated)
Patient registry
No

Interventions

  • Othercollect data

    The data for this project will be obtained directly from the IVI digital work platform (SIVIS) where the characteristics and scans performed to each patient are recorded. Furthermore, it will be recollected information from the time-lapse incubator. For the current study will be used Embryoscope and Geri time-lapse incubators

05

What researchers measure

Primary outcomes

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

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

    Time frame: Since 2018 to april 2020

06

Study locations

1 of 1 sites recruiting
  • IVI Vigo
    Vigo, Pontevedra 36203, Spain
    • Esther Taboas · Contact
    Recruiting
07

References and documents

Publications

  • Basile N, Vime P, Florensa M, Aparicio Ruiz B, Garcia Velasco JA, Remohi J, Meseguer M. The use of morphokinetics as a predictor of implantation: a multicentric study to define and validate an algorithm for embryo selection. Hum Reprod. 2015 Feb;30(2):276-83. doi: 10.1093/humrep/deu331. Epub 2014 Dec 19. PubMed 25527613 ↗
  • Dominguez F, Gadea B, Esteban FJ, Horcajadas JA, Pellicer A, Simon C. Comparative protein-profile analysis of implanted versus non-implanted human blastocysts. Hum Reprod. 2008 Sep;23(9):1993-2000. doi: 10.1093/humrep/den205. Epub 2008 Jun 12. PubMed 18556682 ↗
  • Meseguer M, Herrero J, Tejera A, Hilligsoe KM, Ramsing NB, Remohi J. The use of morphokinetics as a predictor of embryo implantation. Hum Reprod. 2011 Oct;26(10):2658-71. doi: 10.1093/humrep/der256. Epub 2011 Aug 9. PubMed 21828117 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT04736160
Lead sponsor
IVI Vigo
Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Feb 3, 2021
Start date
Dec 5, 2018
Primary completion
Nov 25, 2019
Completion
Nov 25, 2021 (estimated)
Last update
Feb 4, 2021

Study contacts

Elkin Muñoz
Contact
elkin.munoz@ivirma.com
986021860
Esther Taboas
Contact
esther.taboas@ivirma.com
986021860
Elkin Muñoz
study director · IVI Vigo

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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