Trial record 3 of 5 for:    Open Studies | "Pregnancy, Multiple"

Single Human Embryo Transfer in Assisted Reproduction Programs (SET)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Fundacion Para La Investigacion Hospital La Fe.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Inmaculada Molina Botella, Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier:
NCT01471951
First received: November 9, 2011
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Multiple Pregnancies
Other: Single embryo transfer in women at risk of multiple pregnancies
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Single Human Embryo Transfer: Comparison of Morphologic and Morphometric Parameters for Day 2 Embryo Selection Before Transference.

Further study details as provided by Fundacion Para La Investigacion Hospital La Fe:

Primary Outcome Measures:
  • Implantation rate [ Time Frame: 6 weeks after the embryo transference ] [ Designated as safety issue: Yes ]
    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:
  • Morphologic embryo selection [ Time Frame: 48 hours post insemination (day 2) ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 48 hours post insemination (day 2) ] [ Designated as safety issue: Yes ]
    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.


Estimated Enrollment: 154
Study Start Date: November 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01471951

Contacts
Contact: Molina Botella, Ph.D. 0034 961244660 mamobo1@dca.upv.es

Locations
Spain
Hospital Universitari La Fe Recruiting
Valencia, Spain, 46009
Contact: FUNDACION PARA LA INVESTIGACION    +3496 386 27 58    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         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Inmaculada Molina Botella, Head biologist of the human reproduction unit, Fundacion Para La Investigacion Hospital La Fe
ClinicalTrials.gov Identifier: NCT01471951     History of Changes
Other Study ID Numbers: 2011/0329
Study First Received: November 9, 2011
Last Updated: November 15, 2011
Health Authority: Spain: Comité Ético de Investigación Clínica

ClinicalTrials.gov processed this record on July 20, 2014