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:


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:
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 April 22, 2014