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

NCT04744519 | Completed

• 1 other identifier: 1712-VGO-122-EM
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

hCG

Outcome Measures

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)

  Since 2013 to april 2019

Interventions

Collect data OTHER

\- 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

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Donors age \< 32.
• IMC\< 30kg/m2.
• Antral follicle count higher than 8.
• Single Blastocyst transference.
• % oxygen embryo culture,
• time-lapse monitoring incubation KID embryos.

You may not qualify if:

• 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.

Sponsors & Collaborators

• IVI Vigo: lead
• Instituto Valenciano de Infertilidad, IVI VALENCIA: collaborator

Study Sites (1)

IVI Vigo

Vigo, Pontevedra, 36204, Spain

Location

Related Publications (2)

• 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.

  PMID: 24424365 BACKGROUND

• 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: 18556682 BACKGROUND

Study Officials

• Elkin Muñoz

  IVI Vigo

  STUDY DIRECTOR

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 9, 2021
• Study Start: January 20, 2019
• Primary Completion: June 25, 2019
• Study Completion: June 25, 2019
• Last Updated: February 9, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)