Clinical trial NCT04744519: hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy Rates, and Morphokinetics
Official title: hCG Concentration in Peripheral Maternal Blood After Embryo Transfer, Ongoing Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: hCG
Lead sponsor: IVI Vigo
Sponsor class: OTHER
Collaborators: name: Instituto Valenciano de Infertilidad, IVI VALENCIA
First posted: 2021-02-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 32
Standard ages: ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
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.

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.

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.

Eligibility 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.

Primary outcomes:
measure: 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.
timeFrame: Since 2013 to april 2019
Secondary outcomes:
Other outcomes:
Locations:
city: Vigo
country: Spain
facility: IVI Vigo
state: Pontevedra
Study officials:
affiliation: IVI Vigo
name: Elkin Muñoz
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.