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Efficacy Study of the Embryo Transfer Catheter

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00766714
First received: October 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
  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: Open Label
Official Title: The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Clinical pregnancy rates [ Time Frame: End of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rates of difficult transfer [ Time Frame: End of study ] [ Designated as safety issue: No ]
  • Catheter failure rate [ Time Frame: End of study ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
Website of the University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided by University Hospital, Ghent

Additional 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
Study First Received: October 3, 2008
Last Updated: October 3, 2008
Health Authority: Belgium: Institutional Review Board

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

ClinicalTrials.gov processed this record on May 23, 2013