InfertilityNCT01723267
Automated 3D (SonoAVC) Versus 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
A study testing 3D follicles assessment and 2D follicles assessment in people with Infertility, run by Rabin Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- 3D follicles assessment and 2D follicles assessment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2012to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age:18-39, cycle number 1-4
Who cannot join
- PCOS
- Endometriosis
- Poor ovarian response
- TESA sperm
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
Not desired
- Conditions
- Infertility
- Being tested
- 3D follicles assessment, 2D follicles assessment
- Keywords
- IVF, 3D ultrasound, SonoAVC, patients in IVF treatment
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D follicles assessmentOther
3D ultrasound evaluation in IVF treatment (vs 2D ultrasound)
2D follicles assessmentOther
2D ultrasound in IVF treatment (vs 3D ultrasound)
| Study group | Role | What they receive |
|---|---|---|
| 3D follicles assessment | Active comparator | 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. Receives: Other: 3D follicles assessment |
| 2D follicles assessment | Active comparator | During IVF treatment all ultrasound examinations will use standard 2D ultrasound. Timing of hCG injection and oocyte collection will be based on follicle diameter. Receives: Other: 2D follicles assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of matured oocytes
Measured: one IVF cycle (within two weeks)
Secondary outcomes (1)
Fertilization rate in ICSI
Measured: one IVF cycle/ patient (within two weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startDec 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, avi ben haroush, Rabin Medical Center
- Investigators
- Avi Ben-Haroush, MD, Principal investigator, Rabin Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01723267
- Sponsor's protocol ID
- rmcavibh-1
- Status last verified
- Apr 2016
- First submitted
- 12 Jul 2012
- Last updated
- 12 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Automated 3D (SonoAVC) vs 2D Ovarian Follicles Assessment in IVF Cycles: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01723267
- Acronym / sponsor ID
- rmcavibh-1
- Conditions
- Infertility
- Keywords
- IVF, 3D ultrasound, SonoAVC, patients in IVF treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 7 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Not desired
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D follicles assessment | Active comparator | Other: 3D follicles assessmentDuring 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. |
| 2D follicles assessment | Active comparator | Other: 2D follicles assessmentDuring IVF treatment all ultrasound examinations will use standard 2D ultrasound. Timing of hCG injection and oocyte collection will be based on follicle diameter. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age:18-39, cycle number 1-4
Key exclusion criteria (4 listed)
- PCOS
- Endometriosis
- Poor ovarian response
- TESA sperm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D follicles assessment3D ultrasound evaluation in IVF treatment (vs 2D ultrasound) | Other | 3D follicles assessment |
| 2D follicles assessment2D ultrasound in IVF treatment (vs 3D ultrasound) | Other | 2D follicles assessment |
Primary outcome
percentage of matured oocytes
Time frame: one IVF cycle (within two weeks)
1 secondary outcome
Fertilization rate in ICSI
Time frame: one IVF cycle/ patient (within two weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Avi Ben-Haroush, MD principal investigator
Rabin Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D follicles assessment and 2D follicles assessment in people with Infertility, run by Rabin Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of matured oocytes (time frame: one IVF cycle (within two weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2016.