search
Back to results

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
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Infertility

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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

First Posted
November 4, 2015
Last Updated
December 17, 2015
Sponsor
Assiut University
search

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

Learn more about this trial

Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

We'll reach out to this number within 24 hrs