Multiple Pregnancies
Conditions
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.
Interventions
OTHERSingle 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.
Sponsors
Fundacion Para La Investigacion Hospital La Fe
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Spain
Contacts
Primary ContactMolina Botella, Ph.D.
Outcome results
None listed