Single Human Embryo Transfer in Assisted Reproduction Programs

Early Phase 1UnknownNCT01471951

Fundacion Para La Investigacion Hospital La Fe154 enrolled

Overview

Embryo selection based on the use of morphometric parameters should increase the implantation success rate. One of the most important issues of "Assisted Reproduction Technologies (ART)" is the possibility of multiple pregnancies which carries a significant risk for maternal-fetal health. These risks can be reduced by restricting the number of embryos transferred. To do this, it is essential to improve current techniques of embryo selection by developing new tools that would allow the selection of the embryos with higher implantation potential. In previous works (Molina et al 2011) the investigators have demonstrated greater efficacy for the embryo classification systems based on the use of the morphometric variables. The investigators have also developed a profile of embryo implantation using these morphometric variables. In this project the investigators intend to validate the clinical validity of this new embryo classification system by conducting a prospective study of single embryo transfer (SET) in young women at risk of multiple pregnancies.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

154

Conditions

Multiple Pregnancies

Interventions

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Personal and family history without interest, not toxic habits. * Less than 35 years at the time of IVF-ICSI cycle * Sterility of unknown origin or tubal obstruction. Exclusion Criteria: * Repeat nonvoluntary abortions * Endometriosis * Polycystic ovary syndrome (criteria Rotterdam 2004) * Severe male factor (REM \<1 million sperm / ml)

Outcomes

Primary Outcomes

Implantation rate

Pregnancy was defined as a gestational sac with a foetus with heart activity detected through sonography in gestational week 6-8.The implantation rate was defined as the number of gestational sacs per number of transferred embryos.

Time frame: 6 weeks after the embryo transference

Secondary Outcomes

Morphologic embryo selection

The morphological selection will be made by direct observation of the embryo in an inverted microscope phase contrast. Cell number, blastomere symmetry and fragmentation, and structural abnormalities of the zona pellucida (ZP)were recorded

Time frame: 48 hours post insemination (day 2)

Morphometric embryo selection

Morphometric selection will be made by obtaining serial photographs of the embryo that will later be analyzed with an image analysis program that will select the best quality embryos for later transfer The images were analyzed by using ImageJ, a public program developed by Wayne Rasband (http://rsb.info.nih.gov/ij/) and their available tools. The program was used interactively, by applying several of tools and plugins in order to determine the region of interest for the measurements.