Mullerian Duct AnomalyMDA-3DUSNCT01393938
Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
A study testing Three-dimensional ultrasound in people with Mullerian Duct Anomaly, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated to be around 2% in the general population, and 6% to 7% in women with a history of recurrent pregnancy loss. Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Mullerian Duct Anomaly
- What is being tested?
- Three-dimensional ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Feb 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 16 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16
- Patients with suspected Mullerian Duct Anomalies (history of recurrent miscarriage or history of primary or secondary infertility).
- Patients scheduled to undergo routine endovaginal or transabdominal Ultrasonography and pelvic MRI to evaluate possible MDAs
Who cannot join
- Age < 16
- General contraindications to MRI such as pacemaker etc.
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network-Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated to be around 2% in the general population, and 6% to 7% in women with a history of recurrent pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and pregnancy loss varies with the type of MDA. Patients can benefit from surgery or hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize patient outcomes, accurate diagnosis and description of MDAs is essential.
Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI, although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive. Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a reference standard for uterine evaluation. In a study comparing MRI and endovaginal Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.
Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates three-dimensional volumes from a series of two-dimensional images. This technique allows the user to acquire coronal or face-on-view of the uterus which is essential in evaluating the uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7]. Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less expensive than MRI and in some patients better tolerated. If validated using prospective studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.
- Conditions
- Mullerian Duct Anomaly
- Being tested
- Three-dimensional ultrasound
- Keywords
- Mullerian Duct Anomaly, 3-dimensional Ultrasound, Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional ultrasoundOther
Immediately following the standard of care 2D-US, for approximately 15 min.
| Study group | Role | What they receive |
|---|---|---|
| Mullerian Duct Anomaly | Other | Not described Receives: Other: Three-dimensional ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs
Currently the best way for imaging Müllerian Duct Anomalies (MDAs) is Magnetic Resonance Imaging (MRI). In addition, doctors use Two Dimensional Ultrasound (2D-US) to obtain additional pictures of these abnormalities.
Three Dimensional Ultrasound is a new imaging method recently being used to assess these abnormalities. It works in exactly the same way as 2D-US, the only difference being a more up to date computer software, which helps obtain the better images.
This study will assess the accuracy of MRI versus Three Dimensional Ultrasound in viewing and correctly diagnosing MDAs.
Measured: US and MRI within 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2011 (estimated)
- Study startApr 2010
- Primary completionJan 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mullerian Duct AnomalyStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kartik Jhaveri, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01393938
- Sponsor's protocol ID
- UHN090691BE2010
- Acronym
- MDA-3DUS
- Status last verified
- Jan 2015
- First submitted
- 27 May 2011
- Last updated
- 8 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies
- ClinicalTrials.gov ID
- NCT01393938
- Acronym / sponsor ID
- MDA-3DUS / UHN090691BE2010
- Conditions
- Mullerian Duct Anomaly
- Keywords
- Mullerian Duct Anomaly, 3-dimensional Ultrasound, Magnetic Resonance Imaging
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 13 Jul 2011 (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.
Mullerian duct anomalies (MDAs) are relatively common disorders, with a prevalence estimated to be around 2% in the general population, and 6% to 7% in women with a history of recurrent pregnancy loss. Mullerian duct anomalies are associated with recurrent pregnancy loss, intra uterine growth retardation, and preterm labor and birth. The prevalence of preterm birth and pregnancy loss varies with the type of MDA. Patients can benefit from surgery or hysteroscopic interventions like metroplasty based on the type of MDA. Therefore, to optimize patient outcomes, accurate diagnosis and description of MDAs is essential.
Magnetic resonance imaging (MRI) is an excellent way of evaluating the uterus for MDAs. MRI, although costly, is less expensive than laparoscopy and hysteroscopy and is non-invasive. Pellerito et all evaluated 26 women with surgically proven MDAs and found that in 24 cases MRI was able to correctly diagnose the MDAs. Therefore MRI is generally considered as a reference standard for uterine evaluation. In a study comparing MRI and endovaginal Two-Dimensional Ultrasound (2DUS), MRI appeared to be more accurate than 2DUS with a sensitivity of 77%, specificity of 33%, and a positive predictive value of 83%.
Endovaginal Three-Dimensional Ultrasound (3DUS) is a relatively new technology that creates three-dimensional volumes from a series of two-dimensional images. This technique allows the user to acquire coronal or face-on-view of the uterus which is essential in evaluating the uterus for the presence of MDAs. Kupesic and Kurjak used 3DUS to evaluate 86 patients and found that it had sensitivity of 98.38%, specificity of 100%, a positive predictive value of 100%, and a negative predictive value of 96% in the diagnosis of septate uteri [7]. Endovaginal 3DUS is less expensive, less invasive, and less-time consuming than hysteroscopy or MRI and appears to be a very promising technology for the evaluation of MDAs. 3DUS appears to be at least as accurate as MRI in the diagnosis of MDAs. In addition, 3DUS is less expensive than MRI and in some patients better tolerated. If validated using prospective studies, 3DUS has the potential to become the reference standard for the diagnosis of MDAs.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mullerian Duct Anomaly | Other | Other: Three-dimensional ultrasound |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 16
- Patients with suspected Mullerian Duct Anomalies (history of recurrent miscarriage or history of primary or secondary infertility).
- Patients scheduled to undergo routine endovaginal or transabdominal Ultrasonography and pelvic MRI to evaluate possible MDAs
Key exclusion criteria (2 listed)
- Age < 16
- General contraindications to MRI such as pacemaker etc.
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 |
|---|---|---|
| Three-dimensional ultrasoundImmediately following the standard of care 2D-US, for approximately 15 min. | Other | Mullerian Duct Anomaly |
Primary outcome
Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs
Time frame: US and MRI within 1 month
Currently the best way for imaging Müllerian Duct Anomalies (MDAs) is Magnetic Resonance Imaging (MRI). In addition, doctors use Two Dimensional Ultrasound (2D-US) to obtain additional pictures of these abnormalities. Three Dimensional Ultrasound is a new imaging method recently being used to assess these abnormalities. It works in exactly the same way as 2D-US, the only difference being a more up to date computer software, which helps obtain the better images. This study will assess the accuracy of MRI versus Three Dimensional Ultrasound in viewing and correctly diagnosing MDAs.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2015.
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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.
Kartik Jhaveri, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-dimensional ultrasound in people with Mullerian Duct Anomaly, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 2 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: stopped early, as of the sponsor's last update on 8 Jan 2015. 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 Canada. 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 was stopped early. Results are not available in the source record.
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?
Evaluation of 3D US and MRI in the diagnosis and assessment of patients with MDAs (time frame: US and MRI within 1 month). 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 8 Jan 2015.