NCT00766714

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,446

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2005

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

October 3, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2008

Completed
Last Updated

October 6, 2008

Status Verified

October 1, 2008

Enrollment Period

5.9 years

First QC Date

October 3, 2008

Last Update Submit

October 3, 2008

Conditions

Infertility (IVF Patients)

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rates

    End of study

Secondary Outcomes (2)

  • Rates of difficult transfer

    End of study

  • Catheter failure rate

    End of study

Study Arms (2)

1

EXPERIMENTAL

Cook K-SOFT-5100 catheter

Device: Cook K-SOFT-5100 catheter

2

ACTIVE COMPARATOR

Frydman classical catheter

Device: Frydman classical catheter

Interventions

Cook K-SOFT-5100 catheterDEVICE

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

1
Frydman classical catheterDEVICE

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

2

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • patients not giving consent were excluded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Ghent

Ghent, 9000, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 19095665DERIVED

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Petra De Sutter, MD, PhD

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 3, 2008

First Posted

October 6, 2008

Study Start

January 1, 2000

Primary Completion

December 1, 2005

Study Completion

December 1, 2005

Last Updated

October 6, 2008

Record last verified: 2008-10

Locations

BE(1)