NCT07397715 Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
| 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 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2024-03-15 with a primary completion date of 2028-02-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
Contact & Investigator
Gwendolin Manegold-Brauer, Prof. Dr.
PRINCIPAL INVESTIGATOR
Deputy Head Physician, Obstetrics and Prenatal Medicine
Frequently Asked Questions
Who can join the NCT07397715 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Adenomyosis of Uterus. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07397715 currently recruiting?
Yes, NCT07397715 is actively recruiting participants. Contact the research team at gwendolin.manegold-brauer@usb.ch for enrollment information.
Where is the NCT07397715 trial being conducted?
This trial is being conducted at Sosnowiec, Poland, Barcelona, Spain, Basel, Switzerland.
Who is sponsoring the NCT07397715 clinical trial?
NCT07397715 is sponsored by Swiss GO Trial Group. The principal investigator is Gwendolin Manegold-Brauer, Prof. Dr. at Deputy Head Physician, Obstetrics and Prenatal Medicine. The trial plans to enroll 1,000 participants.