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

hCG Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04744519
• Other study ID #: 1712-VGO-122-EM
• Status: Completed
• Start date: January 20, 2019
• Est. completion date: June 25, 2019

Study information

• Verified date: January 2021
• Source: IVI Vigo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: June 25, 2019
• Est. primary completion date: June 25, 2019
• Gender: Female
• Age group: 18 Years to 32 Years

Eligibility

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.

Related Conditions & MeSH terms

• hCG

Intervention

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.

Locations

Country	Name	City	State
Spain	IVI Vigo	Vigo	Pontevedra

Sponsors (2)

Lead Sponsor	Collaborator
IVI Vigo	Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Basile N, Nogales Mdel C, Bronet F, Florensa M, Riqueiros M, Rodrigo L, García-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. — View Citation

Domínguez F, Gadea B, Esteban FJ, Horcajadas JA, Pellicer A, Simón 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 ß-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