NCT04736160

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 5, 2018

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

January 29, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 3, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

January 29, 2021

Last Update Submit

February 3, 2021

Conditions

Embryo Disorder

Outcome Measures

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.

    Since 2018 to april 2020

Interventions

collect dataOTHER

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

Eligibility Criteria

Age18 Years - 41 Years
Sexfemale
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Hydrosalpinx.
  • Any indication of oocyte vitrification

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Vigo

Vigo, Pontevedra, 36203, Spain

RECRUITING

Related Publications (3)

  • 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.

    PMID: 25527613BACKGROUND

  • 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.

    PMID: 18556682BACKGROUND

  • 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.

    PMID: 21828117BACKGROUND

Study Officials

  • Elkin Muñoz

    IVI Vigo

    STUDY DIRECTOR

Central Study Contacts

Elkin Muñoz

CONTACT

986021860elkin.munoz@ivirma.com

Esther Taboas

CONTACT

986021860esther.taboas@ivirma.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2021

First Posted

February 3, 2021

Study Start

December 5, 2018

Primary Completion

November 25, 2019

Study Completion

November 25, 2021

Last Updated

February 4, 2021

Record last verified: 2021-01

Locations

ES(1)