Automatic Volume Calculations During Three-dimensional Sonohysterography.

September 6, 2016 updated by: Artur Ludwin, Ludwin & Ludwin Gynecology, Private Medical Center

Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.

The purpose of this trial is to evaluate the feasibility and reliability of automatic volume calculation of uterine cavity in women with reproductive failures. 3D volumes of uterus and uterine cavity will be acquired during three-dimensional ultrasonography and sonohysterography. After that independent observers will measure offline the uterine cavity volume using automatic volume calculation using SonoAVC general software, and VOCAL software.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

INTRODUCTION

The uterus is one of key organs in reproduction and fetal development. A distorted shape and size of uterine cavity may to have significant impact on the reproductive failures (Chan et al., 2011; Saravelos et al., 2008). Current definitions and classification for uterine morphology and its congenital malformation are still controversial (Grimbizis et al., 2013; 2015; Ludwin and Ludwin, 2015a, b). This is an important barrier for studies evaluating the effectiveness of interventions for women with such conditions (Ludwin et al., 2015 a, b).

The uterine cavity volume is a specific feature of each individual uterus, and together with shape of uterine cavity may play one of the crucial roles in etiology of reproductive failures. To the investigators' knowledge the uterine cavity volume has never been studied in this context (Ludwin et al., 2016).

Recently, the technique of uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation (called SonoHysteroAVC; using SonoAVC software; GE Medical Systems, Zipf, Austria) during three-dimensional sonohysterography has been described (Ludwin et al., 2016). Uterine volume estimation is also potentially possible using Virtual Organ Computer-aided AnaLysis (VOCAL™; GE Medical Systems, Zipf, Austria), as for endometrial volume calculation (Martins et al., 2011).

The investigators believe that SonoHysteroAVC technique might improve the knowledge about uterine anatomy, the diagnostic accuracy of uterine cavity shape imaging, and the management of women with different morphological shapes of the uterine cavity. (Ludwin et al., 2016).

AIMS AND HYPOTHESES

Objective: to assess the inter-observer reliability of measuring the uterine cavity volume by automatic volume calculation.

Hypothesis: inter-observer reliability of the uterine cavity volume estimation using automatic volume calculation is very good.

Additional objective: to compare SonoAVC with VOCAL in uterine cavity volume estimation

DESIGN AND PATIENTS Design:Described elsewhere Setting:Described elsewhere Patients: Described elsewhere Inclusion criteria: Described elsewhere Exclusion criteria: Described elsewhere

Sample size:

The reliability estimates of uterine cavity automatic volume estimation are unknown. The feasibility of automatic volume calculation in deferent uterine condition also is unknown.

The investigators assumed that 100 subjects would be sufficient to obtain precise reliability coefficients (Streiner and Kottner, 2014), and 30 participants is minimal sample size for the feasibility study.

Interventions: Repeated three-dimensional sonohysterography (3D-SIS).

Data acquisition: two 3D data-sets of 3D-SIS per participant (observer 0; Obs0).

Analysis: Observer A (ObsA) will analyze the 1st data-set twice and the 2nd data-set once. Observer B (ObsB) will analyze the 2nd data-set once.

Comparisons:

ObsA-Dataset1 (1st analysis) vs. ObsA-Dataset1 (2nd analysis) to determine of repeatability ObsA-Dataset1 vs. ObsA-Dataset2 to determine variability caused by repeating the procedure ObsA-Dataset2 vs. ObsB-Dataset2 to determine inter-observer variability by reading ObsA-Dataset1 vs. ObsB-Dataset2 to determine inter-observer variability caused by repeating the exam

Outcomes:

i) The concordance correlation coefficient ii) Limits of agreement (LoA) iii) Time needed for acquisition iv) Time needed for analysis

Additional aim:

SonoAVC vs VOCAL (reproducibility and time needed)

Data processing and analysis: The researchers will ensure the confidentiality of sensitive data by minimizing the number of personnel who handles subject data.

Consent: All subjects will be given detailed explanation of the study and a written consent form will be signed by the patient and retained in the investigators' confidential records.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
    • Malopolska
      • Krakow, Malopolska, Poland, 31 521
        • Ludwin & Ludwin Gynecology, Specialist Medical Practice Artur Ludwin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • infertility (12 months trying to conceive without success) and/or two previous miscarriages

Exclusion Criteria:

  • unknown pregnancy (ultrasound examination)
  • menopause
  • precancerous conditions and cancers of female genital tract
  • refused consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SonoHysteroAVC
Three-dimensional sonohysterography is the first point for uterine cavity volume estimation, and it is going to be performed in all participants. The investigators are going to fill the uterine cavity twice by saline solution during single sonohysterography procedure, and acquise the volumetric datasets of uterus for offline analysis. The 3D dataset containing the entire uterine cavity will by analyzed using a personal computer and/or the ultrasound machine with specific softwere.
Procedure: Sonohysterography
Sonohysterography, also known as saline infusion sonography, is a special, minimally invasive ultrasound technique. Sonohysterography is a technique in which fluid is injected through the cervix into the uterus, and ultrasound is used to. It provides pictures of the inside of a woman's uterus. Three-dimensional sonohysterography is based on volumetric scanning of uterus and its cavity during saline infusion.
Other Names:
  • Saline infusion sonography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Concordance correlation coefficient in uterine cavity automated volume calculation
Time Frame: up to 12 months
the concordance correlation coefficient measures the agreement between two variables to evaluate reliability
up to 12 months
Limits of agreement (LoA) in uterine cavity volume estimation
Time Frame: up to 12 months
Limits of agreement are an estimate of the interval within which a proportion of the differences between measurements lie.
up to 12 months
Time needed for acquisition
Time Frame: up to 12 months
Time needed for performing of three-dimensional sonohysterography and for uterine cavity 3D dataset acquisition (time of real-time three-dimensional sonohysterography)
up to 12 months
Time needed for uterine cavity volume analysis
Time Frame: up to 12 months
Time needed for performing of uterine cavity volume calculation in offline analysis
up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwin & Ludwin Gynecology, Private Medical Center

Collaborators

Jagiellonian University
University of Sao Paulo

Investigators

  • Principal Investigator: Artur Ludwin, MD, PhD, Ludwin & Ludwin Gynecology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2016

Primary Completion (Actual)

September 1, 2016

Study Completion (Actual)

September 1, 2016

Study Registration Dates

First Submitted

March 6, 2016

First Submitted That Met QC Criteria

March 10, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

September 7, 2016

Last Update Submitted That Met QC Criteria

September 6, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2/KBL/OIL/2016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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.

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