- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01723267
Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
April 10, 2016 updated by: avi ben haroush, Rabin Medical Center
Automated 3D (SonoAVC) vs 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
Accurate assessment of the size of follicles is important in IVF treatment.Timing of oocyte maturation and subsequent egg collection is largely based on follicle size.
An accurate assessment of follicle size and appropriate timing of HCG result in retrieval of more mature oocytes, improved fertilization and higher pregnancy rates. in 3D technology- fter the capturing of a 3D image of an ovary, SonoAVC automatically analyzes the volume dataset, identifies the boundaries of hypoechoic follicles, and provides estimates of their absolute dimensions.
These measurements include the largest diameters in three orthogonal planes, the mean follicular diameter (MFD), the volume of the follicle, and the volume-based diameter (d(V)) of the follicle.
In the current study the investigators aim to evaluate the use of this automated technique of follicle measurement vs. standard 2D technology on the timing of oocyte maturation and subsequent oocyte retrieval.
The investigators speculate that 3D assessment will increase the rate of mature oocyte collection, and eventually will improve other treatment outcomes such as fertilization rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Not desired
Study Type
Interventional
Enrollment (Actual)
54
Phase
- Not Applicable
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
-
-
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Petach Tikva, Israel, 49100
- IVF Unit, Rabin Medical Center
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-
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 39 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Age:18-39, cycle number 1-4
Exclusion Criteria:
- PCOS
- Endometriosis
- Poor ovarian response
- TESA sperm
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
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 3D follicles assessment
During IVF treatment all ultrasound examinations will use 3D- SonoAVC technology.
Timing of hCG injection and oocyte collection will be based on follicle volume and 3D-volume based diameter.
|
3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)
|
Active Comparator: 2D follicles assessment
During IVF treatment all ultrasound examinations will use standard 2D ultrasound.
Timing of hCG injection and oocyte collection will be based on follicle diameter.
|
2D ultrasound in IVF treatment (vs 3D ultrasound)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
percentage of matured oocytes
Time Frame: one IVF cycle (within two weeks)
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one IVF cycle (within two weeks)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fertilization rate in ICSI
Time Frame: one IVF cycle/ patient (within two weeks)
|
one IVF cycle/ patient (within two weeks)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Avi Ben-Haroush, MD, Rabin Medical Center
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
December 1, 2012
Primary Completion (Actual)
December 1, 2013
Study Completion (Actual)
December 1, 2013
Study Registration Dates
First Submitted
July 12, 2012
First Submitted That Met QC Criteria
November 5, 2012
First Posted (Estimate)
November 7, 2012
Study Record Updates
Last Update Posted (Estimate)
April 12, 2016
Last Update Submitted That Met QC Criteria
April 10, 2016
Last Verified
April 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- rmcavibh-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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