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

NCT ID: NCT04744519

Last Updated: 2021-02-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-01-20

Study Completion Date

2019-06-25

Brief Summary

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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.

Detailed Description

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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.

Conditions

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hCG

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Collect 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.

Intervention Type OTHER

Other Intervention Names

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Collect retrospectively data on embryo implantation rate

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

32 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Valenciano de Infertilidad, IVI VALENCIA

OTHER

Sponsor Role collaborator

IVI Vigo

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elkin Muñoz

Role: STUDY_DIRECTOR

IVI Vigo

Locations

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IVI Vigo

Vigo, Pontevedra, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 24424365 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18556682 (View on PubMed)

Other Identifiers

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1712-VGO-122-EM

Identifier Type: -

Identifier Source: org_study_id

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