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CompletedNCT04744519Updated Feb 9, 2021

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

An observational study in hCG, sponsored by IVI Vigo. Completed at 1 site in Spain. Open to female participants aged 18 Years to 32 Years. Per ClinicalTrials.gov, last updated 2021-02-09.

Sponsored by IVI Vigo · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
300
Ages
18 Years to 32 Years
Sex
Female
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • hCG
03

Who can participate

Ages eligible
18 Years to 32 Years
Sexes eligible
Female
Sampling method
Non-probability sample

Study population

Patients who underwent ICSI with oocyte donation in IVI Vigo under time-lapse monitoring between 2013 and up to June 2019.

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

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.
04

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
300 participants (actual)
Patient registry
No

Interventions

  • OtherCollect data

    - 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.

    Also known as: Collect retrospectively data on embryo implantation rate

05

What researchers measure

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.

    • 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)

    Time frame: Since 2013 to april 2019

06

Study locations

1 site
  • IVI Vigo
    Vigo, Pontevedra 36204, Spain
07

References and documents

Publications

  • Basile N, Nogales Mdel C, Bronet F, Florensa M, Riqueiros M, Rodrigo L, Garcia-Velasco J, Meseguer M. Increasing the probability of selecting chromosomally normal embryos by time-lapse morphokinetics analysis. Fertil Steril. 2014 Mar;101(3):699-704. doi: 10.1016/j.fertnstert.2013.12.005. Epub 2014 Jan 11. PubMed 24424365 ↗
  • 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 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT04744519
Lead sponsor
IVI Vigo
Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
Responsible party
Sponsor
First posted
Feb 9, 2021
Start date
Jan 20, 2019
Primary completion
Jun 25, 2019
Completion
Jun 25, 2019
Last update
Feb 9, 2021

Study contacts

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 ↗

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

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