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NCT07397715Recruiting

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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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) • Ovarian lesions • Sonographic signs of deep infiltrating endometriosis (DIE) • Intracavitary pathology (Fibroid 0-2, polyp, adhesions) • Retained products of conception • \>3 small fibroids below 2 cm in largest diameter FIGO 3-8 (i.e. the presence of three fibroids below 2cm is NOT considered an exclusion criterion) • Presence of any fibroid \>2cm.

Contacts

The trial team's contact details are shown on request.

See the official trial record
Status
Recruiting
Phase
—
Study type
Observational
Countries
Switzerland, Belgium, Poland, Spain
Sponsor
Swiss GO Trial Group(Network / cooperative)
Protocol no.
Swiss-GO-09/BASEC:2023-01484
Conditions
Adenomyosis of Uterus
Interventions
—

Collaborators

University Hospital, Basel, Switzerland

Locations · 5

  • Basel, SwitzerlandUniversity Hospital BaselRecruiting at this site
  • Winterthur, SwitzerlandKantonsspital WinterthurRecruiting at this site
  • Leuven, BelgiumUZ LeuvenRecruiting at this site
  • Sosnowiec, PolandMedical University of SilesiaRecruiting at this site
  • Barcelona, SpainHospital Universitari DexeusRecruiting at this site

In total, worldwide, all 5 sites listed in the registry are recruiting.

Site status per the ClinicalTrials.gov registry (last update posted: October 16, 2026).

This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.

Other identifiers

  • 2023-01484 · other identifier
  • 2023 · NIH grant

See also

Other versions

These results are indicative and do not replace medical advice — discuss them with your doctor.