CClinicalTrials.gg
CompletedNCT00766714Updated Oct 6, 2008

Efficacy Study of the Embryo Transfer Catheter

An interventional study of Cook K-SOFT-5100 catheter and Frydman classical catheter in Infertility (IVF Patients), sponsored by University Hospital, Ghent. Completed at 1 site in Belgium. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2008-10-06.

Sponsored by University Hospital, Ghent · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
1,446
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Infertility (IVF Patients)

Browse trials for

03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 1,446 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

University Hospital, Ghent is the lead sponsor of 665 studies on the registry; 156 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • patients not giving consent were excluded
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,446 participants (actual)

Study arms

  • Experimental
    1

    Cook K-SOFT-5100 catheter

    Device: Cook K-SOFT-5100 catheter

  • Active comparator
    2

    Frydman classical catheter

    Device: Frydman classical catheter

Interventions

  • DeviceCook K-SOFT-5100 catheter

    A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI

  • DeviceFrydman classical catheter

    A Frydman classical catheter was used for embryo transfer in human IVF/ICSI

06

What researchers measure

Primary outcomes

  1. Clinical pregnancy rates

    Time frame: End of study

Secondary outcomes

  1. Rates of difficult transfer

    Time frame: End of study

  2. Catheter failure rate

    Time frame: End of study

07

Study locations

1 site
  • University Hospital Ghent
    Ghent, 9000, Belgium
08

References and documents

Publications

  • 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. doi: 10.1093/humrep/den453. Epub 2008 Dec 18. PubMed 19095665 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 6, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00766714
Lead sponsor
University Hospital, Ghent
First posted
Oct 6, 2008
Start date
Jan 2000
Primary completion
Dec 2005
Completion
Dec 2005
Last update
Oct 6, 2008

Study contacts

Petra De Sutter, MD, PhD
principal investigator · University Hospital, Ghent

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2008. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion