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

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ClinicalTrials.gov Identifier: NCT04744519
Recruitment Status : Completed
First Posted : February 9, 2021
Last Update Posted : February 9, 2021
Sponsor:
Collaborator:
Instituto Valenciano de Infertilidad, IVI VALENCIA
Information provided by (Responsible Party):
IVI Vigo

Study Description
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Brief 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.


Condition or disease Intervention/treatment
hCG Other: Collect data

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.

Study Design
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Study Type : Observational
Actual Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy
Actual Study Start Date : January 20, 2019
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Intervention Details:
  • Other: 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.
    Other Name: Collect retrospectively data on embryo implantation rate

Outcome Measures
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Primary Outcome Measures :
  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)


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 32 Years   (Adult)
Sexes Eligible for Study:   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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04744519


Locations
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Spain
IVI Vigo
Vigo, Pontevedra, Spain, 36204
Sponsors and Collaborators
IVI Vigo
Instituto Valenciano de Infertilidad, IVI VALENCIA
Investigators
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Study Director: Elkin Muñoz IVI Vigo
More Information
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Publications:

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Responsible Party: IVI Vigo
ClinicalTrials.gov Identifier: NCT04744519    
Other Study ID Numbers: 1712-VGO-122-EM
First Posted: February 9, 2021    Key Record Dates
Last Update Posted: February 9, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No