3 Dimensional Sonography Imaging

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.

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Key information

Conditions

New Imaging Modality

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Weill Cornell Medical College

New York, 10065, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

3D Sonography analysis

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.

Primary outcomes

IVF performance

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Official study title

3D Sonographic Volumetric Analysis of Ovarian Follicles.

Important dates

Study start: 2012
Primary completion: 2016
Study completion: 2016
First posted: Jun 7, 2013
Registry last updated: May 8, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.