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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

October 3, 2008
October 3, 2008
January 2000
December 2005   (final data collection date for primary outcome measure)
Clinical pregnancy rates [ Time Frame: End of study ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
  • 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 ]
Same as current
Not Provided
Not Provided
 
Efficacy Study of the Embryo Transfer Catheter
The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Infertility (IVF Patients)
  • Device: Cook K-SOFT-5100 catheter
    A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI
  • Device: Frydman classical catheter
    A Frydman classical catheter was used for embryo transfer in human IVF/ICSI
  • Experimental: 1
    Cook K-SOFT-5100 catheter
    Intervention: Device: Cook K-SOFT-5100 catheter
  • Active Comparator: 2
    Frydman classical catheter
    Intervention: Device: Frydman classical catheter
Yao Z, Vansteelandt S, Van der Elst J, Coetsier T, Dhont M, De Sutter P. The efficacy of the embryo transfer catheter in IVF and ICSI is operator-dependent: a randomized clinical trial. Hum Reprod. 2009 Apr;24(4):880-7. Epub 2008 Dec 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1446
December 2005
December 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • patients not giving consent were excluded
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00766714
UZGhent 002
No
Petra De Sutter, University Hospital Ghent
University Hospital, Ghent
Not Provided
Principal Investigator: Petra De Sutter, MD, PhD University Hospital, Ghent
University Hospital, Ghent
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP