Clinical Validation of Embryo Cinematography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier:
NCT01549262
First received: February 16, 2012
Last updated: August 4, 2014
Last verified: August 2014

February 16, 2012
August 4, 2014
February 2012
July 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.
 
Completed
843
July 2013
July 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 information is only displayed when the study is recruiting subjects
Spain
 
NCT01549262
1009-C-088-IR
No
Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
Instituto Valenciano de Infertilidad, IVI VALENCIA
Not Provided
Not Provided
Instituto Valenciano de Infertilidad, IVI VALENCIA
August 2014

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