Single Human Embryo Transfer in Assisted Reproduction Programs
NCT ID: NCT01471951
Last Updated: 2011-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
154 participants
INTERVENTIONAL
2011-11-30
2014-06-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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single embryo transfer
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.
Interventions
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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 Criteria
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Inclusion Criteria
* Less than 35 years at the time of IVF-ICSI cycle
* Sterility of unknown origin or tubal obstruction.
Exclusion Criteria
* Endometriosis
* Polycystic ovary syndrome (criteria Rotterdam 2004)
* Severe male factor (REM \<1 million sperm / ml)
18 Years
35 Years
FEMALE
No
Sponsors
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Fundacion Para La Investigacion Hospital La Fe
OTHER
Responsible Party
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Inmaculada Molina Botella
Head biologist of the human reproduction unit
Principal Investigators
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Jose J Pertusa, Ph.D.
Role: STUDY_CHAIR
Director of the deparment of Biología Funcional y Análisis de Imagen
Antonio A Pellicer, Ph.D.
Role: STUDY_DIRECTOR
Head of Gynecology and Obstetrics
Inmaculada I Molina, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Embryologist of the Human Reproduction Unit
Locations
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Hospital Universitari La Fe
Valencia, Valencia, Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2011/0329
Identifier Type: -
Identifier Source: org_study_id