Single Human Embryo Transfer in Assisted Reproduction Programs

NCT01471951 | Unknown Early Phase 1 DMC

• 1 other identifier: 2011/0329
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Pregnancies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Morphologic embryo selection

  48 hours post insemination (day 2)

• Morphometric embryo selection

  48 hours post insemination (day 2)

Study Arms (1)

single embryo transfer

EXPERIMENTAL

Other: Single embryo transfer in women at risk of multiple pregnancies

Interventions

Single embryo transfer in women at risk of multiple pregnancies OTHER

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.

single embryo transfer

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Repeat nonvoluntary abortions
• Endometriosis
• Polycystic ovary syndrome (criteria Rotterdam 2004)
• Severe male factor (REM \<1 million sperm / ml)

Sponsors & Collaborators

• Fundacion Para La Investigacion Hospital La Fe: lead

Study Sites (1)

Hospital Universitari La Fe

Valencia, Valencia, 46009, Spain

RECRUITING

MeSH Terms

Interventions

Single Embryo Transfer

Intervention Hierarchy (Ancestors)

Embryo Transfer; Reproductive Techniques, Assisted; Reproductive Techniques; Therapeutics; Investigative Techniques

Study Officials

• Jose J Pertusa, Ph.D.

  Director of the deparment of Biología Funcional y Análisis de Imagen

  STUDY CHAIR

• Antonio A Pellicer, Ph.D.

  Head of Gynecology and Obstetrics

  STUDY DIRECTOR

• Inmaculada I Molina, Ph.D.

  Embryologist of the Human Reproduction Unit

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Molina Botella, Ph.D.

CONTACT

0034 961244660; mamobo1@dca.upv.es

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head biologist of the human reproduction unit

Study Record Dates

• First Submitted: November 9, 2011
• First Posted: November 16, 2011
• Study Start: November 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: June 1, 2014
• Last Updated: November 16, 2011

Record last verified: 2011-11

Locations

ES (1)