Automatic Volume Calculations During Three-dimensional Sonohysterography.
Condition: Infertility,; Abortions, Spontaneous, Habitual
MeSH terms: Infertility; Abortion, Spontaneous
Study type: Interventional

Summary: 
      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.
    

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.
    

Intervention name(s): Sonohysterography
Intervention type(s): Procedure
Intervention description(s): 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 intervention name(s): Saline infusion sonography
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Uterus; Ultrasound