Multiple Pregnancies Clinical Trial
— SETOfficial title:
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.
| Status | Recruiting |
| Enrollment | 154 |
| Est. completion date | June 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years to 35 Years |
| Eligibility |
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) |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Universitari La Fe | Valencia |
| Lead Sponsor | Collaborator |
|---|---|
| Fundacion Para La Investigacion Hospital La Fe |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | 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) | Yes |
| Secondary | 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) | Yes |