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Clinical Validation of Embryo Cinematography

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ClinicalTrials.gov Identifier: NCT01549262
Recruitment Status : Completed
First Posted : March 9, 2012
Last Update Posted : August 5, 2014
Sponsor:
Information provided by (Responsible Party):
Marcos Meseguer, Instituto Valenciano de Infertilidad, IVI VALENCIA

Brief Summary:
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 or disease Intervention/treatment Phase
Embryo Diagnosis and Selection Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673) Device: Observe embryo development Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 843 participants
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
Study Start Date : February 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Arm Intervention/treatment
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.



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


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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

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