Intra- and Interobserver Agreement in the Assessment of Human Embryos

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Thomas D'Hooghe, University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier:
NCT01802801
First received: March 25, 2010
Last updated: February 28, 2013
Last verified: February 2013
  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 University Hospital, Gasthuisberg:

Primary Outcome Measures:
  • Evaluation of the intra- and inter-observer variability in the assessement of human embryos [ Time Frame: / ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • / [ Time Frame: / ] [ Designated as safety issue: No ]
    /


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

Ages Eligible for Study:   up to 3 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01802801

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

No publications provided

Responsible Party: Thomas D'Hooghe, Prof. Dr., University Hospital, Gasthuisberg
ClinicalTrials.gov Identifier: NCT01802801     History of Changes
Other Study ID Numbers: GP12122007
Study First Received: March 25, 2010
Last Updated: February 28, 2013
Health Authority: Belgium: Federale Commissie voor medisch en wetenschappelijk onderzoek op embryo's in vitro

ClinicalTrials.gov processed this record on April 16, 2014