Efficacy Study of the Embryo Transfer Catheter | NCT00766714

Studies
Efficacy Study of the Embryo Transfer Catheter

NCT00766714

Sponsor

University Hospital, Ghent

Status

Completed

Last Update Posted

Oct 6, 2008Estimated

Enrollment

1,446Actual

Phase

Not Applicable

Conditions

Infertility (IVF Patients)

Interventions

Cook K-SOFT-5100 catheter
Frydman classical catheter

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000

Primary Completion Date

Dec 2005Actual

Completion Date

Dec 2005Actual

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 3, 2008

First Posted Date

Oct 6, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2008

Last Update Posted Date

Oct 6, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,446Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Cook K-SOFT-5100 catheter	Device: Cook K-SOFT-5100 catheter
2	Active Comparator	Frydman classical catheter	Device: Frydman classical catheter

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cook K-SOFT-5100 catheter	Device	A Cook K-SOFT-5100 catheter was used for embryo transfer in human IVF/ICSI	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Clinical pregnancy rates		End of study

Secondary Outcomes

Measure	Description	Time Frame
Rates of difficult transfer		End of study
Catheter failure rate		End of study

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

patients not giving consent were excluded

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Petra De Sutter, MD, PhD	University Hospital, Ghent	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital Ghent		Ghent		9000	Belgium

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19095665	Derived	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.

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases