Clinical Validation of Embryo Cinematography

This study is currently recruiting participants.
Verified April 2013 by Instituto Valenciano de Infertilidad, Spain
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01549262
First received: February 16, 2012
Last updated: April 22, 2013
Last verified: April 2013

February 16, 2012
April 22, 2013
February 2012
December 2013   (final data collection date for primary outcome measure)
Ongoing Pregnancy Rate [ Time Frame: confirmed 16-18 weeks after embryo transfer ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01549262 on ClinicalTrials.gov Archive Site
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Clinical Validation of Embryo Cinematography
Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Embryo Diagnosis and Selection
  • Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
    Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.
  • Device: Observe embryo development
    Observe embryo development in the traditional manner
  • Active Comparator: Standard Incubator
    Intervention: Device: Observe embryo development
  • Experimental: ESD Time-lapse Monitoring system
    Intervention: Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
780
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December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Female patients undergoing assisted reproduction with ICSI, first or second cycle
  • 20 to 38 yers old
  • BMI (18-25)
  • No endometriosis,
  • > 6 Metaphse II oocytes
  • Basal FSH < 12 UI
  • AMH > 7pmol/L

Exclusion Criteria:

  • Hydrosalpinx
  • Recurrent pregnancy loss
  • Severe male factor
Female
18 Years to 38 Years
Yes
Contact: Marcos Meseguer, PhD (34) 963050900 marcos.meseguer@ivi.es
Contact: Leslie Atkinson, MA (34) 963050900 leslie.atkinson@ivi.es
Spain
 
NCT01549262
1009-C-088-IR
No
Marcos Meseguer, Instituto Valenciano de Infertilidad, Spain
Instituto Valenciano de Infertilidad, Spain
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Not Provided
Instituto Valenciano de Infertilidad, Spain
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP