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Recruiting NCT07397715

NCT07397715 Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms

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Clinical Trial Summary
NCT ID NCT07397715
Status Recruiting
Phase
Sponsor Swiss GO Trial Group
Condition Adenomyosis of Uterus
Study Type OBSERVATIONAL
Enrollment 1,000 participants
Start Date 2024-03-15
Primary Completion 2028-02-01

Trial Parameters

Condition Adenomyosis of Uterus
Sponsor Swiss GO Trial Group
Study Type OBSERVATIONAL
Phase N/A
Enrollment 1,000
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-03-15
Completion 2028-02-01

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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.

Eligibility Criteria

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 infilt

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