Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus
Primary Purpose
Infertility
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Three dimensional ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Infertility
Eligibility Criteria
Inclusion Criteria:
- women with primary infertility,
- an indication for IVF and
- Suspected arcuate or septate uterus diagnosis based on hysterosalpingography .
Exclusion Criteria:
- were confirmed uterine abnormality by prior office hysteroscopy
Sites / Locations
- Assiut university
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Three dimensional ultrasound
Arm Description
Infertile women with diagnosis of arcuate and septate uterus based on Hystro-salpingography were recruited. All women were examined by Three dimensional ultrasound on day 22 cycle to allow for better delineation of the uterine contour. The outer and inner fundal contours and the length of the fundal notch were examined by Three dimensional ultrasound in the mid-coronal view of the multi-planar and multi-slice display of the uterus. The final diagnosis of the anomalies was based on combined hysteroscopy/laparoscopy examination, the gold standard.
Outcomes
Primary Outcome Measures
Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02597816
Brief Title
Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus
Official Title
Three Dimensional Trans-vaginal Ultrasound to Reevaluate Arcuate Uteri Diagnosed by Hystro-salpingography
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Congenital uterine anomalies are found in 8% of infertile women and 24.5% of infertile women with a history of recurrent miscarriage, with septate and sub-septate uterus being the most common anomalies in these women, Also, septate uterus is the commonest anomaly found in infertile women requiring assisted reproductive technology.
Published data showed improved Cumulative pregnancy rate and live birth rate, and a significant reduction in Miscarriage rate in In Vitro Fertilization women after hysteroscopic metroplasty of both small and large septate compared to non-operated women.
Investigators hypothesized that trans-vaginal three Dimensional Ultrasound will be superior to Hystro-salpingography for the differentiation between arcuate and septate uterus in infertile women scheduled for In Vitro Fertilization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Three dimensional ultrasound
Arm Type
Other
Arm Description
Infertile women with diagnosis of arcuate and septate uterus based on Hystro-salpingography were recruited. All women were examined by Three dimensional ultrasound on day 22 cycle to allow for better delineation of the uterine contour. The outer and inner fundal contours and the length of the fundal notch were examined by Three dimensional ultrasound in the mid-coronal view of the multi-planar and multi-slice display of the uterus. The final diagnosis of the anomalies was based on combined hysteroscopy/laparoscopy examination, the gold standard.
Intervention Type
Radiation
Intervention Name(s)
Three dimensional ultrasound
Primary Outcome Measure Information:
Title
Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women with primary infertility,
an indication for IVF and
Suspected arcuate or septate uterus diagnosis based on hysterosalpingography .
Exclusion Criteria:
were confirmed uterine abnormality by prior office hysteroscopy
Facility Information:
Facility Name
Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
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Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus
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