Single Human Embryo Transfer in Assisted Reproduction Programs

Study Overview
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Brief Summary
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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.

Official Title
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Single Human Embryo Transfer: Comparison of Morphologic and Morphometric Parameters for Day 2 Embryo Selection Before Transference.

Conditions
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Multiple Pregnancies

Intervention / Treatment
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* Other: Single embryo transfer in women at risk of multiple pregnancies


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single embryo transfer<br> | Other: Single embryo transfer in women at risk of multiple pregnancies<br>* Prospective study of single embryo transfers in selected women with good reproductive prognosis and high risk of multiple pregnancies in an IVF-ICSI program.. The day of the embryo transfer, the patients will be randomized by a computer application for morphological and morphometric embryo selection.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 weeks after the embryo transference | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 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. | 48 hours post insemination (day 2) |