Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Recruiting · NCT07397715 · Observational (researchers observe without assigning treatment) · Lead sponsor: Swiss GO Trial Group
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
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.
Where it is running
3 locations listed.
- Hospital Universitari Dexeus - Barcelona, Spain
- Medical University of Silesia - Sosnowiec, Poland
- University Hospital Basel - Basel, Canton of Basel-City, Switzerland