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Efficacy Study of the Embryo Transfer Catheter

NCT ID: NCT00766714

Last Updated: 2008-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1446 participants

Study Classification

INTERVENTIONAL

Study Start Date

2000-01-31

Study Completion Date

2005-12-31

Brief Summary

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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

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Conditions

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Infertility (IVF Patients)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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1

Cook K-SOFT-5100 catheter

Group Type EXPERIMENTAL

Cook K-SOFT-5100 catheter

Intervention Type DEVICE

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

2

Frydman classical catheter

Group Type ACTIVE_COMPARATOR

Frydman classical catheter

Intervention Type DEVICE

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

Interventions

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Cook K-SOFT-5100 catheter

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

Intervention Type DEVICE

Frydman classical catheter

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* patients not giving consent were excluded
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Ghent

OTHER

Sponsor Role lead

Responsible Party

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University Hospital Ghent

Principal Investigators

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Petra De Sutter, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 19095665 (View on PubMed)

Related Links

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http://www.uzgent.be

Website of the University Hospital Ghent

Other Identifiers

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UZGhent 002

Identifier Type: -

Identifier Source: org_study_id