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Sponsored by: |
University Hospital, Ghent |
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Information provided by: | University Hospital, Ghent |
ClinicalTrials.gov Identifier: | NCT00766714 |
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 |
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Infertility (IVF Patients) |
Device: Cook K-SOFT-5100 catheter Device: Frydman classical catheter |
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 |
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 |
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1: Experimental
Cook K-SOFT-5100 catheter
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Device: Cook K-SOFT-5100 catheter
A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI
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2: Active Comparator
Frydman classical catheter
|
Device: Frydman classical catheter
A Frydman classical catheter was used for embryo transfer in human IVF/ICSI
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Genital Diseases, Female Infertility Genital Diseases, Male |