Clinical trial NCT02505555: Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
Official title: Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Four Dimensional Hysterosalpingo-contrast Sonography
Tubal Patency
Keywords: feasibility
accuracy
tolerability
four dimensional hysterosalpingo-contrast sonography
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2015-07-22
Enrollment: 380
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who have infertility and try to evaluate tubal patency by 4D-HyCoSy in our hospital will be recruited.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue
timeFrame: at least one year
Secondary outcomes:
measure: side effects and complications of four-dimensional hysterosalpingo-contrast sonography
timeFrame: at least one year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
Study officials:
References:
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. Italian.
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.
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/humrep/deu024. Epub 2014 Feb 26.
citation: 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. 2013 Mar;41(3):328-35. doi: 10.1002/uog.11200.
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.
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. No abstract available.
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. doi: 10.1186/1471-2342-13-28.
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):256-9. doi: 10.1016/j.ijgo.2010.07.018. Epub 2010 Sep 17.
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.
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. No abstract available.