3 Dimensional Sonography Imaging

Completed

• Conditions: New Imaging Modality
• Interventions: Other: 3D Sonography analysis

• Registration Number: NCT01872559
• Lead Sponsor: Weill Medical College of Cornell University

Brief Summary

The study is designed to evaluate a new imaging modality, 3-dimmensional sonographic volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is currently in place. Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do no require any additional sonograms, tests, or interventions. All patients are eligible (oocyte donors and autologous oocyte patients) and only patients with a serum estradiol \> 2000pg/ML will be enrolled in the study. After the additional measurements are obtained, the results will be digitally stored. The results of the 3D sonographic volumetric analysis will then be correlated with the patients' IVF performance.

Detailed Description

The benefits of the study is that 3-dimensional sonographic volumetric analysis may be a superior imaging modality for sonographically assessing oocyte maturity and may lead to change in clinical practice. The lone risk of the study is rooted in protecting the patients' protected health information.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-05-21
• Study First Submitted QC: 2013-06-04
• Study First Posted: 2013-06-07
• Primary Completion: 2016-09-13
• Study Completion: 2016-09-16
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-03
• Last Update Posted: 2017-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

• All patients (oocyte donors and autologous oocyte patients)with a serum estradiol > 2000pg/ML.

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Exclusion Criteria

• All patients not meeting the estradiol criteria.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
3D sonographic analysis	3D Sonography analysis	The study is designed to evaluate a new imaging modality, 3D sonographic volumetric analysis, and compare it to the conventional 2-dimmensional analysis that is currently in place. Those patients who are scheduled to have an ultrasound as part of their infertility treatment will be offered the opportunity to have additional measurements done at the time of their ultrasound; these additional measurements will take less than 2 minutes and do no require any additional sonograms, tests, or interventions.

Primary Outcome Measures

Name	Time	Method
IVF performance	3 weeks	Correlations for age of patient, BMI, documented 2-dimensional sonographic analysis, type of oocyte maturation trigger, serum estradiol prior to trigger, serum estradiol after trigger, number of oocyte retrieved, number of mature oocytes retrieved, embryo grade, type of incubator utilized, day 3 or day 5 transfer, implantation rate, and ultimate pregnancy will be made with the volumetric analysis.

Trial Locations

Locations (1)

Weill Cornell Medical College; 🇺🇸 New York, New York, United States