Four Dimensional Hysterosalpingo-contrast SonographyNCT02505555
Feasibility of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
An observational study of Four Dimensional Hysterosalpingo-contrast Sonography and Tubal Patency, run by Peking University First Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Four Dimensional Hysterosalpingo-contrast Sonography, Tubal Patency
- What is being tested?
- four dimensional hysterosalpingo-contrast sonography
- Type of treatment
- Medical device
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Feb 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Women who have infertility and try to evaluate tubal patency by 4D-HyCoSy in our hospital will be recruited.
Who may be able to join
- Women who have infertility and need to evaluate tubal patency.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital
Beijing, Beijing Municipality, 100034
Wen Pei Bai, M.D., +86 133-6615-7805 ext. 10 8357 2211, bwp66@163.com
About this study
Official title: Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
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.
- Being tested
- four dimensional hysterosalpingo-contrast sonography
- Keywords
- feasibility, accuracy, tolerability, four dimensional hysterosalpingo-contrast sonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
four dimensional hysterosalpingo-contrast sonographyDevice
Also called 4D-HyCoSy
compare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue
Sensitivity, specificity, accuracy, positive predictive value, negative predictive value
Measured: at least one year
Secondary outcomes (1)
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
Measured: at least one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startFeb 2013
- Primary completionFeb 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Four Dimensional Hysterosalpingo-contrast SonographyStudies of the same condition, open and under way.
- More trials run by Peking University First HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University First Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bai Wen-Pei, Peking University First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505555
- Sponsor's protocol ID
- PekingUFH-4DF
- Other IDs
- 4D-HyCoSy
- Status last verified
- Jul 2015
- First submitted
- 4 Jul 2015
- Last updated
- 22 Jul 2015
- Results posted
- No
Publications
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.
PubMed 21311415Luciano 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.
PubMed 24910933Maheux-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.
PubMed 24578476Exacoustos 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.
PubMed 22648792He 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.
PubMed 23804346Tur-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.
PubMed 22535627Marci 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.
PubMed 23968513Socolov 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.
PubMed 20850745Giugliano 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.
PubMed 23346526O'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.
PubMed 24567574
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
- ClinicalTrials.gov ID
- NCT02505555
- Acronym / sponsor ID
- PekingUFH-4DF
- Keywords
- feasibility, accuracy, tolerability, four dimensional hysterosalpingo-contrast sonography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- Peking University First HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Feb 2016 (estimated)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Women who have infertility and try to evaluate tubal patency by 4D-HyCoSy in our hospital will be recruited.
Key inclusion criteria (1 listed)
- Women who have infertility and need to evaluate tubal patency.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| four dimensional hysterosalpingo-contrast sonographyAlso: 4D-HyCoSycompare accuracy and tolerability of 4D-HyCoSy with that of laparoscopy and chromotubation | Device | – |
Primary outcome
Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue
Time frame: at least one year
Sensitivity, specificity, accuracy, positive predictive value, negative predictive value
1 secondary outcome
side effects and complications of four-dimensional hysterosalpingo-contrast sonography
Time frame: at least one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
- Results publication: PubMed 21311415Marana 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.
- Results publication: PubMed 24910933Luciano 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.
- Results publication: PubMed 24578476Maheux-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.
- Results publication: PubMed 22648792Exacoustos 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.
- Results publication: PubMed 23804346He 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.
- Results publication: PubMed 22535627Tur-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.
- Results publication: PubMed 23968513Marci 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.
- Results publication: PubMed 20850745Socolov 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.
- Results publication: PubMed 23346526Giugliano 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.
- Results publication: PubMed 24567574O'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.
- Related InfoLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Four Dimensional Hysterosalpingo-contrast Sonography and Tubal Patency, run by Peking University First Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wen pei Bai, M.D. (+86 133-6615-7805 ext. 10 8357 221, bwp66@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity and specificity of four-dimensional hysterosalpingo-contrast sonography with SonoVue (time frame: at least one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505555, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.