Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions

June 16, 2021 updated by: Xiaowu Huang, Fu Xing Hospital, Capital Medical University

The Value of Three-dimensional Ultrasound Applying in Pre and Postoperative Assessment and Prognosis of Intrauterine Adhesions

In this prospective, multicenter, large-scale study，the investigators wish to examine the accuracy of several three-dimensional ultrasound anatomical and vascular parameters in diagnosing IUA when compared to the gold standard of hysteroscopy，and to assess the value of 3D US applying in prognosis of intrauterine adhesions.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

  1. Study Design This is a prospective, multicenter, large-scale diagnostic testing. We use hysteroscopy finding as standard reference.
  2. Study population 600 patients from three tertiary hospitals suspected of having IUA will be prospectively recruited. Thorough assessment including previous reproductive and surgical history as well as menstrual pattern will be performed.
  3. Study Procedure 3.1 Diagnosis

IUA will be diagnosed in coronal plane, based on a suggestion reported by a Taiwanese study. The morphological characteristics of the endometrium suggesting IUA include as follow:

  • marginal irregularity (in coronal plane)
  • defects (interrupted endometrial line)
  • obliteration (undetectable endometrium suggesting extensive adhesion)
  • fibrosis or calcification (hyperechoic lesion without posterior shadowing, or with posterior shadowing) 3.2 Ultrasound
  • Transvaginal Ultrasound will be performed in luteal phase.
  • Using E10 Voluson GE with 3D/4D TV probe.
  • Scan and rendering will be performed in a standardized technique (omniview mode).
  • Several parameters will be measured including endometrial volume, uterine volume, vascularization (VI FI VFI).

3.3 Hysteroscopy

  • Hysteroscopic exam will be used as the gold standard for the diagnosis of intrauterine adhesions.
  • hysteroscopy will confirm the presence, extent, and morphological characteristics of adhesions and the quality of the endometrium.

3.4 Surgical technique

  • Hysteroscopic surgery will be performed in a standardized manner.
  • The severity and extent of intrauterine adhesions will be scored according to different classification systems. (ESGE/AFS/China consensus)
  • a Foley-catheter filled with 3.0ml normal saline will be inserted into the uterus for 5-7 days after surgery.

3.5 Postoperative treatments

  • All subjects will be treated with Hormone therapy for at least 8 weeks
  • A second-look hysteroscopy will be carried out 4 weeks after surgery, a third-look hysteroscopy will be carried out 12 weeks after surgery
  • A second-look 3D US will be carried out in luteal phase after two menstrual peroid postoperatively.

3.6 Follow up

  • Follow-up styles: the doctor's outpatient review, telephone, WeChat and so on.
  • Follow-up time:3 months, 6months, 12 months after the operation.
  • Follow up the results of hysteroscopy and 3D US at 3 months after the operation and the menstrual improvement at 6months after the operation and pregnancy outcomes at 12 months after the operation

Study Type

Observational

Enrollment (Anticipated)

600

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

Study Locations

  • China
      • Beijing, China, 100038
        • Recruiting
        • Fu Xing Hospital, Capital Medical University

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

20 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

600 patients from three Tertiary hospitals suspected of having IUA will be prospectively recruited

Description

Inclusion Criteria:

  • women aged 20-40
  • oligomenorrhea or amenorrhea
  • BMI 18-30
  • regular menstruation
  • written consent obtained

Exclusion Criteria:

  • Hypothalamic amenorrhea, pituitary amenorrhea and ovarian amenorrhea
  • Patients with uterine fibroids, adenomyosis, uterine malformation and endometrial polyps
  • Patients with uterine artery embolization
  • History of endometrial hyperplasia
  • Irregular menstruation
  • Patients with severe complications
  • Patients with hypoovarian function

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
Endometrial volume
Time Frame: 1 year
Endometrial volume will be measured in in luteal phase by 3D US
1 year

Collaborators and Investigators

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

Sponsor

Fu Xing Hospital, Capital Medical University

Investigators

  • Study Chair: Li Tinchiu, Fuxing Hospital,Capital Medical University

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

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 (ACTUAL)

July 1, 2020

Primary Completion (ANTICIPATED)

June 30, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (ACTUAL)

June 18, 2021

Study Record Updates

Last Update Posted (ACTUAL)

June 18, 2021

Last Update Submitted That Met QC Criteria

June 16, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020-1-7027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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