- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01393938
Comparison of MRI Versus Three Dimensional Ultrasound in the Diagnosis of Mullerian Duct Anomalies (MDA-3DUS)
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Ontario
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Toronto, Ontario, Canada, M5G 2M9
- University Health Network-Princess Margaret Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Age < 16
- General contraindications to MRI such as pacemaker etc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Mullerian Duct Anomaly
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Immediately following the standard of care 2D-US, for approximately 15 min.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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. |
US and MRI within 1 month
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UHN090691BE2010
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.
Clinical Trials on Mullerian Duct Anomaly
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Wake Forest University Health SciencesRecruitingCongenital Mullerian Duct AnomalyUnited States
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University Hospital, GhentRecruitingMullerian Anomaly of Uterus, Nec | Mullerian Anomaly of Vagina | Mullerian Anomaly of CervixBelgium
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University Hospital, GhentRecruitingMullerian Anomaly of Uterus, Nec | Mullerian Anomaly of Vagina | Mullerian Anomaly of CervixBelgium
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Aljazeera HospitalKasr El Aini Hospital; National Research Centre, Egypt; misr Infertility centre...Unknown
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Assiut UniversityRecruitingMullerian Duct AnomaliesEgypt
-
Clinique OvoTerminated
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ART Fertility Clinics LLCCompletedAnti-Mullerian Hormone IsoformsUnited Arab Emirates
-
ART Fertility Clinics LLCCompletedAnti-Mullerian Hormone ResistanceUnited Arab Emirates
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University of California, San DiegoWithdrawnMajor Fetal AnomalyUnited States
-
Beckman Coulter, Inc.Completed
Clinical Trials on Three-dimensional ultrasound
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Chinese University of Hong KongCompleted
-
Assiut UniversityCompleted
-
Fu Xing Hospital, Capital Medical UniversityRecruitingIntrauterine AdhesionChina
-
Mahidol UniversityCompleted
-
Assiut UniversityCompleted
-
Lewisham and Greenwich NHS TrustCompletedObstetric Anal Sphincter InjuryUnited Kingdom
-
Jagiellonian UniversityRecruiting
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Croydon Health Services NHS TrustCompletedAnal Sphincter Injury | Obstetric Trauma | Perineal Infection | Perineum; InjuryUnited Kingdom
-
sherine Hosny Mohamed Gad AllahUnknownPatients With Recurrent Unexplained Pregnancy LossEgypt
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Assiut UniversityCompleted