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Intra- and Interobserver Agreement in the Assessment of Human Embryos

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01802801
First Posted: March 1, 2013
Last Update Posted: March 1, 2013
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):
Thomas D'Hooghe, University Hospital, Gasthuisberg
  Purpose
The purpose of this study is to determine the intra- and interobserver agreement.

Condition Intervention
the Focus of This Study is to Measure the Intra- and Interobserver Agreement for the Evaluation of Early Stage Embryos Other: embryo development

Study Type: Observational
Official Title: Intra-and Inter-observer Agreement in the Morphological Assessment of Human Embryos

Further study details as provided by Thomas D'Hooghe, University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Evaluation of the intra- and inter-observer variability in the assessement of human embryos
    Variation in observer assessment of embryo characteristics on day 1, 2 and 3 of embryo development. Assessment of these characteristics is standard procedure. Safety and tolerability or efficacy issues are not relevant for this outcome.


Enrollment: 50
Study Start Date: December 2007
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
1 Other: embryo development
intra- and inter-observator analysis

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 3 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
embryos of IVF/ICSI patients
Criteria

Inclusion Criteria:

  • fertilized embryos

Exclusion Criteria:

  • unfertilized embryos
  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): NCT01802801


Locations
Belgium
University Hospital Leuven, Catholic University Leuven
Leuven, Belgium
Sponsors and Collaborators
University Hospital, Gasthuisberg
  More Information

Responsible Party: Thomas D'Hooghe, Prof. Dr., University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01802801     History of Changes
Other Study ID Numbers: GP12122007
First Submitted: March 25, 2010
First Posted: March 1, 2013
Last Update Posted: March 1, 2013
Last Verified: February 2013