Single Human Embryo Transfer in Assisted Reproduction Programs

Early Phase 1

• Conditions: Multiple Pregnancies
• Interventions: Other: Single embryo transfer in women at risk of multiple pregnancies

• Registration Number: NCT01471951
• Lead Sponsor: Fundacion Para La Investigacion Hospital La Fe

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-11
• Study Start: 2011-11
• Study First Submitted: 2011-11-09
• Study First Submitted QC: 2011-11-15
• Last Update Submitted: 2011-11-15
• Study First Posted: 2011-11-16
• Last Update Posted: 2011-11-16
• Primary Completion: 2013-12
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 154

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single embryo transfer	Single embryo transfer in women at risk of multiple pregnancies	-

Primary Outcome Measures

Name	Time	Method
Implantation rate	6 weeks after the embryo transference	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.

Secondary Outcome Measures

Name	Time	Method
Morphologic embryo selection	48 hours post insemination (day 2)	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
Morphometric embryo selection	48 hours post insemination (day 2)	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.

Trial Locations

Locations (1)

Hospital Universitari La Fe; 🇪🇸 Valencia, Spain