- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01872559
3 Dimensional Sonography Imaging
May 3, 2017 updated by: Weill Medical College of Cornell University
3D Sonographic Volumetric Analysis of Ovarian Follicles.
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Observational
Enrollment (Actual)
2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Weill Cornell Medical College
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Glenn Schattman, MD, Weill Medical College of Cornell University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2012
Primary Completion (Actual)
September 13, 2016
Study Completion (Actual)
September 16, 2016
Study Registration Dates
First Submitted
May 21, 2013
First Submitted That Met QC Criteria
June 4, 2013
First Posted (Estimate)
June 7, 2013
Study Record Updates
Last Update Posted (Actual)
May 8, 2017
Last Update Submitted That Met QC Criteria
May 3, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Other Study ID Numbers
- 1209013095
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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