Single Human Embryo Transfer in Assisted Reproduction Programs (SET)

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

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 Overview

• Status: Unknown
• Conditions: Multiple Pregnancies
• Intervention / Treatment: Other: Single embryo transfer in women at risk of multiple pregnancies

• Study Type: Interventional
• Enrollment (Anticipated): 154
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Molina Botella, Ph.D.; Phone Number: 0034 961244660; Email: mamobo1@dca.upv.es

Study Locations

• Spain
  • Valencia, Spain, 46009
    • Recruiting
    • Hospital Universitari La Fe
    • Contact: FUNDACION PARA LA INVESTIGACION; Phone Number: +3496 386 27 58; Email: ceic@fundacionlafe.org
    • Sub-Investigator: Montañana Vicente, Ph.D
    • Sub-Investigator: Martinez Juan Vicente
    • Sub-Investigator: Rubio Jose Maria, Ph.D
    • Sub-Investigator: Polo Patrocinio, Ph.D
    • Sub-Investigator: Balasch Sebastian, Ph.D
    • Sub-Investigator: Garcia Trinidad, Ph.D
    • Sub-Investigator: Marzal Alicia
    • Sub-Investigator: Taronger Roser, Ph.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: single embryo transfer	Other: Single embryo transfer in women at risk of multiple pregnancies; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Fundacion Para La Investigacion Hospital La Fe
• Investigators: Study Chair: Jose J Pertusa, Ph.D., Director of the deparment of Biología Funcional y Análisis de Imagen; Study Director: Antonio A Pellicer, Ph.D., Head of Gynecology and Obstetrics; Principal Investigator: Inmaculada I Molina, Ph.D., Embryologist of the Human Reproduction Unit

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Anticipated): December 1, 2013
• Study Completion (Anticipated): June 1, 2014

Study Registration Dates

• First Submitted: November 9, 2011
• First Submitted That Met QC Criteria: November 15, 2011
• First Posted (Estimate): November 16, 2011

Study Record Updates

• Last Update Posted (Estimate): November 16, 2011
• Last Update Submitted That Met QC Criteria: November 15, 2011
• Last Verified: November 1, 2011

More Information

Terms related to this study

• Other Study ID Numbers: 2011/0329