3 Dimensional Sonography Imaging

NCT ID: NCT01872559

Last Updated: 2017-05-08

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

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-12-31

Study Completion Date

2016-09-16

Brief Summary

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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

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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.

Conditions

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New Imaging Modality

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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3D sonographic 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.

3D Sonography analysis

Intervention Type OTHER

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 not require any additional sonograms, tests, or interventions.

Interventions

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3D Sonography analysis

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 not require any additional sonograms, tests, or interventions.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* All patients not meeting the estradiol criteria.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Glenn Schattman, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Weill Cornell Medical College

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1209013095

Identifier Type: -

Identifier Source: org_study_id

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