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3 Dimensional Sonography Imaging

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ClinicalTrials.gov Identifier: NCT01872559
Recruitment Status : Completed
First Posted : June 7, 2013
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
New Imaging Modality Other: 3D Sonography analysis

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.

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Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 3D Sonographic Volumetric Analysis of Ovarian Follicles.
Actual Study Start Date : December 2012
Actual Primary Completion Date : September 13, 2016
Actual Study Completion Date : September 16, 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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.
Other: 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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
In Vitro fertilization patients and donor egg patients of the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine who at the day of monitoring (having an ultrasound and blood work drawn) have an estradiol level greater than 2000pg/ML.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01872559


Locations
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United States, New York
Weill Cornell Medical College
New York, New York, United States, 10065
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
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Principal Investigator: Glenn Schattman, MD Weill Medical College of Cornell University

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Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT01872559     History of Changes
Other Study ID Numbers: 1209013095
First Posted: June 7, 2013    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017