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Clinical Validation of Embryo Cinematography

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01549262
First Posted: March 9, 2012
Last Update Posted: August 5, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA
  Purpose
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.

Condition Intervention
Embryo Diagnosis and Selection Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) Device: Observe embryo development

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Diagnostic
Official Title: Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

Further study details as provided by Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Ongoing Pregnancy Rate [ Time Frame: confirmed 16-18 weeks after embryo transfer ]

Enrollment: 843
Study Start Date: February 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Incubator Device: Observe embryo development
Observe embryo development in the traditional manner
Experimental: ESD Time-lapse Monitoring system 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 38 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01549262


Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, IVI VALENCIA
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcos Meseguer, Embryologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01549262     History of Changes
Other Study ID Numbers: 1009-C-088-IR
First Submitted: February 16, 2012
First Posted: March 9, 2012
Last Update Posted: August 5, 2014
Last Verified: August 2014