Efficacy Study of the Embryo Transfer Catheter - Full Text View

Sponsored by:	University Hospital, Ghent
Information provided by:	University Hospital, Ghent
ClinicalTrials.gov Identifier:	NCT00766714

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

MedlinePlus related topics: Infertility

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial

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
1: Experimental 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
2: Active Comparator 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

Website of the University Hospital Ghent This link exits the ClinicalTrials.gov site

Responsible Party:	University Hospital Ghent ( Petra De Sutter )
Study ID Numbers:	UZGhent 002
Study First Received:	October 3, 2008
Last Updated:	October 3, 2008
ClinicalTrials.gov Identifier:	NCT00766714
Health Authority:	Belgium: Institutional Review Board

Study placed in the following topic categories:

Genital Diseases, Female
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on January 16, 2009