NCT02710006|CompletedDMC
Automatic Volume Calculations During Three-dimensional Sonohysterography.
Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.
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Feasibility and Reliability of Assessing Uterine Cavity Volume by SonoAVC in Women With Reproductive Failure.
Sponsor study identifier
interventional
100
1 country
1
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
March 6, 2016
Actual (reported)March 16, 2016
Actual (reported)September 2016
Actual (reported)September 2016
Actual (reported)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
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
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
Time needed for uterine cavity volume analysis
Time needed for performing of uterine cavity volume calculation in offline analysis
up to 12 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Ludwin & Ludwin Gynecology, Specialist Medical Practice Artur Ludwin
Krakow, Malopolska, 31 521, Poland
Ludwin A, Ludwin I. Comparison of the ESHRE-ESGE and ASRM classifications of Mullerian duct anomalies in everyday practice. Hum Reprod. 2015 Mar;30(3):569-80. doi: 10.1093/humrep/deu344. Epub 2014 Dec 22.
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. No abstract available.
Artur Ludwin, MD, PhD
Ludwin & Ludwin Gynecology
100 participants (actual enrollment reported by the registry).
First Submitted
March 6, 2016
First Posted
March 16, 2016
Study Start
February 2016
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
Grimbizis GF, Gordts S, Di Spiezio Sardo A, Brucker S, De Angelis C, Gergolet M, Li TC, Tanos V, Brolmann 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.
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.
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.
Ludwin A, Martins WP, Ludwin I. Uterine cavity imaging, volume estimation and quantification of degree of deformity using automatic volume calculation: description of technique. Ultrasound Obstet Gynecol. 2017 Jul;50(1):138-140. doi: 10.1002/uog.15890. Epub 2017 May 28. No abstract available.
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):1970-1979. doi: 10.1111/jan.12402. Epub 2014 Mar 30.
Primary Completion
September 2016
Actual (reported)Study Completion
September 2016
Actual (reported)Last Updated
September 7, 2016
Record last verified: 2016-09
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