Automatic Volume Calculations During Three-dimensional Sonohysterography.

NCT02710006 | Completed DMC

• 1 other identifier: 2/KBL/OIL/2016
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility,; Abortions, Spontaneous, Habitual

Keywords

Uterus; Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

SonoHysteroAVC

EXPERIMENTAL

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

Interventions

Sonohysterography PROCEDURE

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.

Also known as: Saline infusion sonography

SonoHysteroAVC

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ludwin & Ludwin Gynecology, Private Medical Center: lead
• Jagiellonian University: collaborator
• University of Sao Paulo: collaborator

Study Sites (1)

Ludwin & Ludwin Gynecology, Specialist Medical Practice Artur Ludwin

Krakow, Malopolska, 31 521, Poland

Location

Related Publications (11)

• 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.

  PMID: 25534461 BACKGROUND

• 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.

  PMID: 26525503 BACKGROUND

• 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.

  PMID: 24581576 BACKGROUND

• 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.

  PMID: 21465609 BACKGROUND

• 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.

  PMID: 25175693 BACKGROUND

• 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.

  PMID: 21830244 BACKGROUND

• 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.

  PMID: 23771171 BACKGROUND

• 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.

  PMID: 26537921 BACKGROUND

• 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.

  PMID: 26158905 BACKGROUND

• 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.

  PMID: 26919726 BACKGROUND

• 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.

  PMID: 24684713 BACKGROUND

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Artur Ludwin, MD, PhD

  Ludwin & Ludwin Gynecology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Artur Ludwin MD, PhD

Study Record Dates

• First Submitted: March 6, 2016
• First Posted: March 16, 2016
• Study Start: February 1, 2016
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: September 7, 2016

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)