Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-01

Study Completion Date

2023-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Treatment of Intrauterine Adhesions and Its Distribution of Genital Tract Flora

NCT03731689

Intrauterine Adhesions

UNKNOWN NA

Sonohysterography , 3D Ultrasonography and Hysteroscopy in Assessment of Uterine Factor in Cases of Female Infertility

NCT02399501

Infertility

COMPLETED NA

Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis

NCT06795711

Adenomyosis

RECRUITING

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

NCT02505555

Four Dimensional Hysterosalpingo-contrast Sonography Tubal Patency

UNKNOWN

Detection of the Uterine Abnormalities Missed in an Ultrasound Scan and/or Hysterosalpingography Using Hysteroscopy, in Females Presenting With Unexplained Infertility

NCT04179253

Infertility, Female

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intrauterine Adhesion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Three-dimensional Ultrasound

women suspected of having adhesions will perform 3D US

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No