Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT
This study has been completed.
Sponsor:
University of Wisconsin, Madison
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00682071
First received: May 16, 2008
Last updated: NA
Last verified: May 2008
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | May 16, 2008 | ||||
| Last Updated Date | May 16, 2008 | ||||
| Start Date ICMJE | August 2003 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
pregnancy rates for TAS and TVS ultrasound-guided ET groups [ Time Frame: August 2003 to June 2007 ] [ 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 | Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT | ||||
| Official Title ICMJE | Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial | ||||
| Brief Summary | Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. We sought to determine if either approach was better with respect to clinical outcomes. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients undergoing assisted reproductive cycles at the University of Wisconsin REI Program |
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| Condition ICMJE |
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| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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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 | 224 | ||||
| Completion Date | June 2007 | ||||
| Primary Completion Date | June 2007 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria: - All patients undergoing assisted reproductive cycles including autologous IVF, oocyte donation, and frozen embryo transfer (FET) cycles Exclusion Criteria: - Cases of severe ovarian hyper-stimulation requiring embryo cryopreservation and gestational surrogate cycles |
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00682071 | ||||
| Other Study ID Numbers ICMJE | 2003-311, IRB# 2003-311 (UW), HSC# 2003-311 (UW), Grant: OB/GYN R&D, Funding # 133-FZ71 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Steven R. Lindheim, MD, MMM, Fertility Specialists Medical Group, San Diego, CA | ||||
| Study Sponsor ICMJE | University of Wisconsin, Madison | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Wisconsin, Madison | ||||
| Verification Date | May 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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