Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
2 other identifiers
observational
380
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 4, 2015
CompletedFirst Posted
Study publicly available on registry
July 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2016
CompletedJuly 22, 2015
July 1, 2015
3 years
July 4, 2015
July 21, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue
Sensitivity, specificity, accuracy, positive predictive value, negative predictive value
at least one year
Secondary Outcomes (1)
side effects and complications of four-dimensional hysterosalpingo-contrast sonography
at least one year
Interventions
compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation
Eligibility Criteria
Women who have infertility and try to evaluate tubal patency by 4D-HyCoSy in our hospital will be recruited.
You may qualify if:
- Women who have infertility and need to evaluate tubal patency.
You may not qualify if:
- vaginal bleeding;
- acute or subacute inflammation of the reproductive system;
- uterine malignancies;
- allergies to the medications used in the examination, such as lidocaine, atropine, and sulfur hexafluoride
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Related Publications (10)
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.
PMID: 21311415RESULTLuciano 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.
PMID: 24910933RESULTMaheux-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.
PMID: 24578476RESULTExacoustos 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.
PMID: 22648792RESULTHe 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.
PMID: 23804346RESULTTur-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.
PMID: 22535627RESULTMarci 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.
PMID: 23968513RESULTSocolov 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.
PMID: 20850745RESULTGiugliano 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.
PMID: 23346526RESULTO'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.
PMID: 24567574RESULT
Related Links
Central Study Contacts
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor,Chief of Obstetrics and Gynecology Department
Study Record Dates
First Submitted
July 4, 2015
First Posted
July 22, 2015
Study Start
February 1, 2013
Primary Completion
February 1, 2016
Last Updated
July 22, 2015
Record last verified: 2015-07