Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms

NCT07397715 | Recruiting

• 2 other identifiers: Swiss-GO-09/BASEC:2023-014842023-01484
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 3

Brief Summary

The goal of this study/research is to assess the relationship between ultrasound features of the myometrium suggestive of adenomyosis and clinical symptoms of adenomyosis and to establish a reporting system for adenomyosis assessing disease severity. Consecutive pre- and perimenopausal symptomatic and asymptomicasymptomatic women with an uterus presenting for gynaecological ultrasound exams will be asked to participate in the study. Routine gynecologicalgynaecological ultrasound exams will be performed and study participants will fill out a questionnaire on their symptoms (if any) and bleeding pattern. There will be one visit and no interventions.

Conditions

Adenomyosis of Uterus

Keywords

Adenomyoma; Deep infiltrating endometriosis; Gynaecological transvaginal ultrasound; Gynaecological Ultrasound; Myometrium; Uterine anomaly; Asymptomatic adenomyosis; Symptomatic adenomyosis; Menstrual bleeding; Bleeding disorders; Abnormal uterine bleeding; Abdominal pain; Dysmenorrhoea; Dyspareunia; Morphological Uterus Sonographic Assessment (MUSA); Adenomyosis Grading; Subfertility; Ultrasound features; Myometrial cysts; Hyperechogenic island; Echogenic subendometrial lines and buds; Globular uterus; Asymmetrical myometrial thickening; Fan shaped shadowing; Cyclical/non-cyclical bleeding; menorrhagia; Metrorrhagia; Translesional vascularity; Irregular junctional zone; Interrupted junctional zone; benign fibroid; Myoma

Outcome Measures

Primary Outcomes (1)

• Association between MUSA defined ultrasound features of adenomyosis and the severity of clinical symptoms.

  The correlation between the total number of MUSA defined ultrasound features (presence/absence; feature count) and clinical symptom severity will be assessed using the Numeric Rating Scale (NRS 0-10) for pain and the Pictorial Blood Assessment Chart (PBAC) score for abnormal bleeding. The primary outcome will be expressed as a correlation coefficient (unitless).

  At baseline (single assessment at the time of the routine ultrasound examination)

Secondary Outcomes (3)

• Association of individual ultrasound features with symptom severity

  At baseline (single assessment at the time of the routine ultrasound examination)

• Prevalence of individual MUSA defined features

  At baseline (single assessment at the time of the routine ultrasound examination.

• Prevalence of Ultrasound Features in Symptomatic vs. Asymptomatic Participants

  At baseline (single assessment at the time of the routine ultrasound examination

Other Outcomes (1)

• Exploratory Development of an Ultrasound Based Severity Grading System

  At baseline (single assessment at the time of the routine ultrasound examination).

Study Arms (1)

Women with a uterus

Pre - and perimenopausal women with a uterus that are scheduled for a gynaecologic ultrasound exam.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.

You may qualify if:

• Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.
• Symptomatic and asymptomatic women
• Patients with hormonal contraceptives and Hormone Replacement Therapy (HRT) can be included, but information will be noted.

You may not qualify if:

• Missing written consent (study consent)
• Any serious underlying medical, psychiatric or psychological condition, which may interfere with the patient's capacity of discernment.
• Postmenopausal women
• Pregnancy
• History of pelvic urogynaecologic surgery (TVT, mesh surgery, etc.)
• Malignancy or premalignancy of uterus/cervix
• Prior myomectomy for FIGO 3-6 fibroids
• Patients with coagulation disorders under current anticoagulation medication
• Prior history of diagnosed intraabdominal adhesions (surgery)
• Prior diagnosis of pelvic congestion syndrome
• Psychiatric disease precluding a reliable estimation of pain
• Prior surgery or treatment for deep infiltrating endometriosis
• Acute other symptoms:
• Urinary symptoms (dysuria, urgency, grade III stress incontinence)
• Acute of chronic pelvic infection (cervicitis, endometritis, salpingitis, frozen pelvis)

Sponsors & Collaborators

• Swiss GO Trial Group: lead
• University Hospital, Basel, Switzerland: collaborator

Study Sites (3)

Medical University of Silesia

Sosnowiec, 41-200, Poland

RECRUITING

Hospital Universitari Dexeus

Barcelona, 08028, Spain

RECRUITING

University Hospital Basel

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Adenomyosis; Adenomyoma; Uterine Anomalies; Hemostatic Disorders; Metrorrhagia; Abdominal Pain; Dysmenorrhea; Dyspareunia; Infertility; Menorrhagia; Myoma

Condition Hierarchy (Ancestors)

Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Neoplasms; Vascular Diseases; Cardiovascular Diseases; Hemorrhagic Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive; Menstruation Disturbances; Pelvic Pain; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue

Study Officials

• Gwendolin Manegold-Brauer, Prof. Dr.

  Deputy Head Physician, Obstetrics and Prenatal Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gwendolin Manegold-Brauer, Prof. Dr.

CONTACT

+41612659046; gwendolin.manegold-brauer@usb.ch

Team Swiss GO Trial Group, +41613284203

CONTACT

pm-team@swiss-go.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: February 9, 2026
• Study Start: March 15, 2024
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): February 1, 2029
• Last Updated: February 12, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF
• Time Frame: The estimated time time from which the data will become available will be from 1st of February 2029 onwards.
• Access Criteria: Access to, provision and exchange of data, including the metadata, between the Parties under the Project (Data) shall be carried out pursuant to the Data Transfer and Use Agreement by the Parties for accessing, providing or exchanging Data under the Project.

Locations

ES (1); PL (1); CH (1)