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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 23, 2014