Efficacy Study of the Embryo Transfer Catheter

Not Applicable

Completed

• Conditions: Infertility (IVF Patients)
• Interventions: Device: Cook K-SOFT-5100 catheter; Device: Frydman classical catheter

• Registration Number: NCT00766714
• Lead Sponsor: University Hospital, Ghent

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2000-01
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Status Verified: 2008-10
• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-03
• Last Update Submitted: 2008-10-03
• Study First Posted: 2008-10-06
• Last Update Posted: 2008-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1446

Inclusion Criteria

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

Exclusion Criteria

• patients not giving consent were excluded

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Cook K-SOFT-5100 catheter	Cook K-SOFT-5100 catheter
2	Frydman classical catheter	Frydman classical catheter

Primary Outcome Measures

Name	Time	Method
Clinical pregnancy rates	End of study

Secondary Outcome Measures

Name	Time	Method
Rates of difficult transfer	End of study
Catheter failure rate	End of study

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, Belgium