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

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ClinicalTrials.gov Identifier: NCT02505555
Recruitment Status : Unknown
Verified July 2015 by Bai Wen-Pei, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : July 22, 2015
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Bai Wen-Pei, Peking University First Hospital

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.

Condition or disease Intervention/treatment
Four Dimensional Hysterosalpingo-contrast Sonography Tubal Patency Device: four dimensional hysterosalpingo-contrast sonography

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Study Type : Observational
Estimated Enrollment : 380 participants
Time Perspective: Prospective
Official Title: Accuracy and Tolerability of Four-dimensional Hysterosalpingo-contrast Sonography With SonoVue for Assessment of Tubal Patency
Study Start Date : February 2013
Estimated Primary Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound


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


Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. side effects and complications of four-dimensional hysterosalpingo-contrast sonography [ Time Frame: at least one year ]
    the intensity of pain perception, vaginal bleeding, fever, pelvic inflammatory diseases,peritonitis,and the pregnancy outcomes



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02505555


Contacts
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Contact: Wen pei Bai, M.D. +86 133-6615-7805 ext 10 8357 221 bwp66@163.com

Locations
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China, Beijing
Peking University First Hospital Recruiting
Beijing, Beijing, China, 100034
Contact: Wen Pei Bai, M.D.    +86 133-6615-7805 ext 10 8357 2211    bwp66@163.com   
Sponsors and Collaborators
Peking University First Hospital

Additional Information:
Publications of Results:

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Responsible Party: Bai Wen-Pei, Professor,Chief of Obstetrics and Gynecology Department, Peking University First Hospital
ClinicalTrials.gov Identifier: NCT02505555     History of Changes
Other Study ID Numbers: PekingUFH-4DF
4D-HyCoSy ( Other Identifier: PekingUFH )
First Posted: July 22, 2015    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: July 2015
Keywords provided by Bai Wen-Pei, Peking University First Hospital:
feasibility
accuracy
tolerability
four dimensional hysterosalpingo-contrast sonography