Efficacy Study of the Embryo Transfer Catheter
This study has been completed.
Sponsor:
University Hospital, Ghent
Information provided by:
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00766714
First received: October 3, 2008
Last updated: NA
Last verified: October 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | October 3, 2008 | ||||
| Last Updated Date | October 3, 2008 | ||||
| Start Date ICMJE | January 2000 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Clinical pregnancy rates [ Time Frame: End of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Efficacy Study of the Embryo Transfer Catheter | ||||
| Official Title ICMJE | The Efficacy of the Embryo Transfer Catheter in IVF and ICSI is Operator-Dependent: a Randomized Clinical Trial | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label |
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| Condition ICMJE | Infertility (IVF Patients) | ||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | 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. Epub 2008 Dec 18. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 1446 | ||||
| Completion Date | December 2005 | ||||
| Primary Completion Date | December 2005 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Belgium | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00766714 | ||||
| Other Study ID Numbers ICMJE | UZGhent 002 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Petra De Sutter, University Hospital Ghent | ||||
| Study Sponsor ICMJE | University Hospital, Ghent | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Ghent | ||||
| Verification Date | October 2008 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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