Role of Three Dimensional Ultrasound in the Diagnosis of Septate Uterus

Phase 2

Completed

• Conditions: Infertility
• Interventions: Radiation: Three dimensional ultrasound

• Registration Number: NCT02597816
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-10
• Study Start: 2013-10
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Study First Submitted: 2015-11-04
• Study First Submitted QC: 2015-11-04
• Study First Posted: 2015-11-05
• Last Update Submitted: 2015-12-17
• Last Update Posted: 2015-12-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 38

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Three dimensional ultrasound	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.

Primary Outcome Measures

Name	Time	Method
Number of patients diagnosed to have subseptate uterus by three dimensional ultrasound	1 year

Trial Locations

Locations (1)

Assiut university; 🇪🇬 Assiut, Egypt