Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

Three Dimensional Trans-vaginal Ultrasound to Reevaluate Arcuate Uteri Diagnosed by Hystro-salpingography

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Radiation: Three dimensional ultrasound

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 2

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71111
    • Assiut University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Three dimensional ultrasound; 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.

Radiation: Three dimensional ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: November 4, 2015
• First Submitted That Met QC Criteria: November 4, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Estimate): December 18, 2015
• Last Update Submitted That Met QC Criteria: December 17, 2015
• Last Verified: October 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: TDU