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

July 21, 2015 updated by: Bai Wen-Pei, Peking University First Hospital

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

380

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Wen pei Bai, M.D.
  • Phone Number: 10 8357 221 +86 133-6615-7805
  • Email: bwp66@163.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
          • Wen Pei Bai, M.D.
          • Phone Number: 10 8357 2211 +86 133-6615-7805
          • Email: bwp66@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at least one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
at least one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (ANTICIPATED)

February 1, 2016

Study Registration Dates

First Submitted

July 4, 2015

First Submitted That Met QC Criteria

July 21, 2015

First Posted (ESTIMATE)

July 22, 2015

Study Record Updates

Last Update Posted (ESTIMATE)

July 22, 2015

Last Update Submitted That Met QC Criteria

July 21, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • PekingUFH-4DF
  • 4D-HyCoSy (OTHER: PekingUFH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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