Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT02710006
Status:
COMPLETED
Last Update Posted:
2016-09-07
First Post:
2016-03-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Automatic Volume Calculations During Three-dimensional Sonohysterography.
Sponsor:
Ludwin & Ludwin Gynecology, Private Medical Center
Organization:
Study Overview
Official Title:
Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.
Status:
COMPLETED
Status Verified Date:
2016-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: