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Efficacy Study of the Embryo Transfer Catheter

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00766714
First Posted: October 6, 2008
Last Update Posted: October 6, 2008
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:
University Hospital, Ghent
  Purpose
A prospective randomized trial comparing Cook K-SOFT-5100 and Frydman classical catheter 4.5 for embryo transfer in human IVF/ICSI was performed. Three experienced operators participated in the trial, using a fixed distance transfer protocol. Primary endpoint was clinical pregnancy rate, secondary endpoints were rates of difficult transfer and of catheter failure. Patients were randomized by a computer program immediately prior to embryo transfer.

Condition Intervention
Infertility (IVF Patients) Device: Cook K-SOFT-5100 catheter Device: Frydman classical catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Clinical pregnancy rates [ Time Frame: End of study ]

Secondary Outcome Measures:
  • Rates of difficult transfer [ Time Frame: End of study ]
  • Catheter failure rate [ Time Frame: End of study ]

Enrollment: 1446
Study Start Date: January 2000
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Cook K-SOFT-5100 catheter
Device: Cook K-SOFT-5100 catheter
A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI
Active Comparator: 2
Frydman classical catheter
Device: Frydman classical catheter
A Frydman classical catheter was used for embryo transfer in human IVF/ICSI

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients undergoing embryo transfer in our IVF program between 2000 and 2005

Exclusion Criteria:

  • patients not giving consent were excluded
  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): NCT00766714


Locations
Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Petra De Sutter, University Hospital Ghent
ClinicalTrials.gov Identifier: NCT00766714     History of Changes
Other Study ID Numbers: UZGhent 002
First Submitted: October 3, 2008
First Posted: October 6, 2008
Last Update Posted: October 6, 2008
Last Verified: October 2008

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female