Automatic Volume Calculations During Three-dimensional Sonohysterography.

Abortions, Spontaneous, Habitual Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02710006
• Other study ID #: 2/KBL/OIL/2016
• Status: Completed
• Phase: N/A
• First received: March 6, 2016
• Last updated: September 6, 2016
• Start date: February 2016
• Est. completion date: September 2016

Study information

• Verified date: September 2016
• Source: Ludwin & Ludwin Gynecology, Private Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Abortions, Spontaneous, Habitual
• Infertility
• Infertility,

Intervention

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.

Locations

Country	Name	City	State
Poland	Ludwin & Ludwin Gynecology, Specialist Medical Practice Artur Ludwin	Krakow	Malopolska

Sponsors (3)

Lead Sponsor	Collaborator
Ludwin & Ludwin Gynecology, Private Medical Center	Jagiellonian University, University of Sao Paulo

Country where clinical trial is conducted

Poland, 

References & Publications (11)

Chan YY, Jayaprakasan K, Tan A, Thornton JG, Coomarasamy A, Raine-Fenning NJ. Reproductive outcomes in women with congenital uterine anomalies: a systematic review. Ultrasound Obstet Gynecol. 2011 Oct;38(4):371-82. doi: 10.1002/uog.10056. Review. — View Citation

Coelho Neto MA, Roncato P, Nastri CO, Martins WP. True Reproducibility of UltraSound Techniques (TRUST): systematic review of reliability studies in obstetrics and gynecology. Ultrasound Obstet Gynecol. 2015 Jul;46(1):14-20. doi: 10.1002/uog.14654. Epub 2015 Jun 4. Review. — View Citation

Grimbizis GF, Di Spiezio Sardo A, Saravelos SH, Gordts S, Exacoustos C, Van Schoubroeck D, Bermejo C, Amso NN, Nargund G, Timmerman D, Athanasiadis A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Tarlatzis B, Farquharson R, Gianaroli L, Campo R. The Thessaloniki ESHRE/ESGE consensus on diagnosis of female genital anomalies. Hum Reprod. 2016 Jan;31(1):2-7. doi: 10.1093/humrep/dev264. Epub 2015 Nov 4. — View Citation

Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brölmann H, Gianaroli L, Campo R. The ESHRE/ESGE consensus on the classification of female genital tract congenital anomalies. Hum Reprod. 2013 Aug;28(8):2032-44. doi: 10.1093/humrep/det098. Epub 2013 Jun 14. — View Citation

Ludwin A, Ludwin I, Kudla M, Kottner J. Reliability of the European Society of Human Reproduction and Embryology/European Society for Gynaecological Endoscopy and American Society for Reproductive Medicine classification systems for congenital uterine anomalies detected using three-dimensional ultrasonography. Fertil Steril. 2015 Sep;104(3):688-97.e8. doi: 10.1016/j.fertnstert.2015.06.019. Epub 2015 Jul 7. — View Citation

Ludwin A, Ludwin I, Kudla M, Pitynski K, Banas T, Jach R, Knafel A. Diagnostic accuracy of three-dimensional sonohysterography compared with office hysteroscopy and its interrater/intrarater agreement in uterine cavity assessment after hysteroscopic metroplasty. Fertil Steril. 2014 May;101(5):1392-9. doi: 10.1016/j.fertnstert.2014.01.039. Epub 2014 Feb 26. — View Citation

Ludwin A, Ludwin I. Comparison of the ESHRE-ESGE and ASRM classifications of Müllerian duct anomalies in everyday practice. Hum Reprod. 2015 Mar;30(3):569-80. doi: 10.1093/humrep/deu344. Epub 2014 Dec 22. — View Citation

Ludwin A, Ludwin I. Diagnostic rate and accuracy of the ESHRE-ESGE classification for septate uterus and other common uterine malformations: why do we not see that the Emperor is naked? Ultrasound Obstet Gynecol. 2015 Nov;46(5):634-6. doi: 10.1002/uog.14941. — View Citation

Ludwin A, Martins WP, Ludwin I. Uterine cavity imaging, volume estimation, and quantification of deformity degree using automatic volume calculation: description of the technique. Ultrasound Obstet Gynecol. 2016 Feb 26. doi: 10.1002/uog.15890. [Epub ahead of print] — View Citation

Martins WP, Raine-Fenning NJ, Leite SP, Ferriani RA, Nastri CO. A standardized measurement technique may improve the reliability of measurements of endometrial thickness and volume. Ultrasound Obstet Gynecol. 2011 Jul;38(1):107-15. doi: 10.1002/uog.9016. Epub 2011 Apr 28. — View Citation

Streiner DL, Kottner J. Recommendations for reporting the results of studies of instrument and scale development and testing. J Adv Nurs. 2014 Sep;70(9):1970-9. doi: 10.1111/jan.12402. Epub 2014 Mar 30. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Concordance correlation coefficient in uterine cavity automated volume calculation	the concordance correlation coefficient measures the agreement between two variables to evaluate reliability	up to 12 months	No
Primary	Limits of agreement (LoA) in uterine cavity volume estimation	Limits of agreement are an estimate of the interval within which a proportion of the differences between measurements lie.	up to 12 months	No
Primary	Time needed for acquisition	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	No
Primary	Time needed for uterine cavity volume analysis	Time needed for performing of uterine cavity volume calculation in offline analysis	up to 12 months	No