An observational study in Adenomyosis of Uterus, sponsored by Swiss GO Trial Group. Recruiting at 5 sites in 4 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-16.
Sponsored by Swiss GO Trial Group · Observational
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.
In adenomyosis endometrial tissue is embedded in the myometrium of the uterus. It is considered a relevant benign, underreported disease of the uterus and is a frequent cause of dysmenorrhea, bleeding disorders and abdominal pain and subfertility. The reference standard for diagnosis is histology, but the majority of women will have hormonal medical treatment, are in the reproductive age and will not undergo surgery (i.e. hysterectomy). Today ultrasound has become the first line imaging method for diagnosis.
The proportion of women that show ultrasound features of adenomyosis without symptoms is unknown but a third of young, nulliparous women without other associated disease will show signs of adenomyosis.
The MUSA consensus describes ultrasound features suggestive of adenomyosis: asymmetrical thickening of the myometrium, cysts within the myometrium, echogenic subendometrial lines and buds, hyperechoic islands, fan shaped shadowing and an irregular or interrupted junctional zone. More recently the MUSA criteria have been specified further and now distinguish between direct features, that are typical for adenomyosis and indirect features that result from ectopic endometrium in the myometrium.
This is a cross sectional exploratory non-interventional observational multicenter study with one visit and no interventions with assessment of participant demographics, standardized assessment of bleeding, standardized assessment of pain, standardized ultrasound exam.
The primary objective of the study is to assess the relationship between MUSA-defined ultrasound features of the myometrium suggestive of adenomyosis and the severity of clinical symptoms, specifically pain (NRS) and abnormal uterine bleeding (PBAC).
Secondary objectives are:
The participants are consecutively enrolled at the sites when they present for a scheduled gynecologic ultrasound exam, fit the inclusion criteria, and do not have any positive exclusion criteria.
The files or referrals of the participants will be screened for eligibility at the participating site's department. Participants will be included if they have signed the consent for the study (ideally prior to the ultrasound exam, but recruitment after the routine exam is also possible). Since the ultrasound data is assessed within routine care the additional exam time for the participants should be almost unchanged. The filling out of the questionnaire for assessment of pain and bleeding will take some extra time (10-15min). The clinical and ultrasound data will be entered into the electronic patient file immediately by the examiner and the transfer into the data miner will occur within one month of the ultrasound exam by the examining physician or a member of the study team.
The investigators plan to include 1000 participants from at least seven centres in Europe and Switzerland. Out of that the investigators plan to include 400 from Switzerland. The study duration is estimated to be three years.
142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 57 observational studies indexed under Adenomyosis.
Browse Adenomyosis studies →Swiss GO Trial Group is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women of pre- and perimenopausal age presenting for gynaecologic ultrasound exam giving voluntary informed written consent.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pre - and perimenopausal women with a uterus that are scheduled for a gynaecologic ultrasound exam.
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).
Time frame: At baseline (single assessment at the time of the routine ultrasound examination)
Association of individual ultrasound features with symptom severity
Each individual MUSA defined ultrasound feature (binary: yes/no) will be evaluated for its association with pain severity (NRS 0-10) and bleeding severity (PBAC score). Results will be reported as an effect size or correlation coefficient (unitless).
Time frame: At baseline (single assessment at the time of the routine ultrasound examination)
Prevalence of individual MUSA defined features
The proportion of participants who exhibit each individual MUSA defined ultrasound feature will be reported.
Time frame: At baseline (single assessment at the time of the routine ultrasound examination.
Prevalence of Ultrasound Features in Symptomatic vs. Asymptomatic Participants
The percentages of symptomatic participants (pain and/or abnormal bleeding) and asymptomatic participants exhibiting each MUSA defined ultrasound feature will be compared.
Time frame: At baseline (single assessment at the time of the routine ultrasound examination
Exploratory Development of an Ultrasound Based Severity Grading System
An exploratory grading system integrating MUSA defined ultrasound findings with clinical symptom scores (NRS and PBAC) will be developed to propose a categorical severity classification for adenomyosis.
Time frame: At baseline (single assessment at the time of the routine ultrasound examination).
Plan to share: Yes — Parties can use and may share Data under their custodianship with any third party providing analyses within the Project, if and to the extent required for the Project, provided that the Data: (i) are disposed in accordance with all necessary patient consents, regulatory approvals and the purpose of the Project, under terms at least equivalent to those of this Consortium Agreement and the data transfer and use agreement(s) and (ii) remain confidential and are published only after the publication of the results from the currently planned project and after approval of the Steering Committee.
Supporting information: Informed consent form
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.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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