Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

Tubal Patency Clinical Trial

Official title:

Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02505555
• Other study ID #: PekingUFH-4DF
• Secondary ID: 4D-HyCoSy
• Status: Recruiting
• Phase: N/A
• First received: July 4, 2015
• Last updated: July 21, 2015
• Start date: February 2013

Study information

• Verified date: July 2015
• Source: Peking University First Hospital
• Contact: Wen pei Bai, M.D.
• Phone: +86 133-6615-7805
• Email: bwp66[@]163.com
• Is FDA regulated: No
• Health authority: China: Chinese Ethics Committee of Registering Clinical Trials
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to summarize our experience with and to evaluate the feasibility of transvaginal four-dimensional hysterosalpingo-contrast sonography using SonoVue (4D-HyCoSy) for assessment of fallopian tubal patency, women attending the fertility clinic are recruited. All of the patients are tried to be examined with 4D-HyCoSy,some of who undergone laparoscopy and dye. Then the results of 4D-HyCoSy and lap and dye are compared. All of the patients will be followed up. The complications of 4D-HyCoSy will be evaluated and the pregnancy outcomes will be recorded.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 380
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women who have infertility and need to evaluate tubal patency.

Exclusion Criteria:

1. vaginal bleeding;

2. acute or subacute inflammation of the reproductive system;

3. uterine malignancies;

4. allergies to the medications used in the examination, such as lidocaine, atropine, and sulfur hexafluoride

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Four Dimensional Hysterosalpingo-contrast Sonography
• Tubal Patency

Intervention

Device:
• four dimensional hysterosalpingo-contrast sonography
compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University First Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

Exacoustos C, Di Giovanni A, Szabolcs B, Romeo V, Romanini ME, Luciano D, Zupi E, Arduini D. Automated three-dimensional coded contrast imaging hysterosalpingo-contrast sonography: feasibility in office tubal patency testing. Ultrasound Obstet Gynecol. 20 — View Citation

Giugliano E, Cagnazzo E, Bazzan E, Patella A, Marci R. Hysterosalpingo-contrast sonography: is possible to quantify the therapeutic effect of a diagnostic test? Clin Exp Reprod Med. 2012 Dec;39(4):161-5. doi: 10.5653/cerm.2012.39.4.161. Epub 2012 Dec 31. — View Citation

He Y, Geng Q, Liu H, Han X. First experience using 4-dimensional hysterosalpingo-contrast sonography with SonoVue for assessing fallopian tube patency. J Ultrasound Med. 2013 Jul;32(7):1233-43. doi: 10.7863/ultra.32.7.1233. — View Citation

Luciano DE, Exacoustos C, Luciano AA. Contrast ultrasonography for tubal patency. J Minim Invasive Gynecol. 2014 Nov-Dec;21(6):994-8. doi: 10.1016/j.jmig.2014.05.017. Epub 2014 Jun 6. Review. — View Citation

Maheux-Lacroix S, Boutin A, Moore L, Bergeron ME, Bujold E, Laberge P, Lemyre M, Dodin S. Hysterosalpingosonography for diagnosing tubal occlusion in subfertile women: a systematic review with meta-analysis. Hum Reprod. 2014 May;29(5):953-63. doi: 10.1093 — View Citation

Marana R, Ferrari S, Merola A, Astorri AL, Pompa G, Milardi D, Giampietro A, Lecca A, Marana E. [Role of a mini-invasive approach in the diagnosis and treatment of tubo-peritoneal infertility as an altenative to IVF]. Minerva Ginecol. 2011 Feb;63(1):1-10. — View Citation

Marci R, Marcucci I, Marcucci AA, Pacini N, Salacone P, Sebastianelli A, Caponecchia L, Lo Monte G, Rago R. Hysterosalpingocontrast sonography (HyCoSy): evaluation of the pain perception, side effects and complications. BMC Med Imaging. 2013 Aug 23;13:28. — View Citation

O'Flynn N. Assessment and treatment for people with fertility problems: NICE guideline. Br J Gen Pract. 2014 Jan;64(618):50-1. doi: 10.3399/bjgp14X676609. — View Citation

Socolov D, Boian I, Boiculese L, Tamba B, Anghelache-Lupascu I, Socolov R. Comparison of the pain experienced by infertile women undergoing hysterosalpingo contrast sonography or radiographic hysterosalpingography. Int J Gynaecol Obstet. 2010 Dec;111(3):2 — View Citation

Tur-Kaspa I. Fear no pain: uterine cavity and tubal patency assessment tests should be pain free. Ultrasound Obstet Gynecol. 2012 Mar;39(3):247-51. doi: 10.1002/uog.11128. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue	Sensitivity, specificity, accuracy, positive predictive value, negative predictive value	at least one year	Yes
Secondary	side effects and complications of four-dimensional hysterosalpingo-contrast sonography	the intensity of pain perception, vaginal bleeding, fever, pelvic inflammatory diseases,peritonitis,and the pregnancy outcomes	at least one year	Yes

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