Improving ultrasound diagnosis of adenomyosis
Validation and Optimisation of Ultrasound Diagnosis of Adenomyosis: a Prospective Observational Study
This study is trying to improve how well ultrasound can diagnose adenomyosis in women by looking at specific measurements of the uterus.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 465 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Trial ID | NCT06795711 on ClinicalTrials.gov |
What this trial studies
This study aims to enhance the accuracy of ultrasound in diagnosing adenomyosis by establishing specific biometric parameters of the uterus. It will categorize patients into three groups based on their uterine conditions: those with adenomyosis, those with fibromatosis, and those with a normal uterus. The research focuses on the use of transvaginal ultrasound, a non-invasive diagnostic tool, to assess the prevalence of uterine abnormalities and their impact on reproductive health. By refining ultrasound criteria, the study seeks to improve diagnostic reliability and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 60 who can provide informed consent and are experiencing symptoms related to adenomyosis.
Not a fit: Patients who have undergone a hysterectomy, are virgins, have gynaecological oncology issues, or are menopausal may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of adenomyosis, potentially improving treatment options and outcomes for affected patients.
How similar studies have performed: While transvaginal ultrasound is a well-established diagnostic tool, this specific approach to optimizing its use for adenomyosis is novel and has not been extensively tested in previous studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * age between 18 and 60; * obtaining informed consent Exclusion Criteria: * Hysterectomised patients; * Virgo patients (hymenal integrity); * Patients reporting intolerance to transvaginal ultrasound; * Gynaecological oncology; * Recent pregnancy or childbirth (within 6 months); * Menopausal patients
Where this trial is running
Bologna, Bologna
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (Recruiting)
Study contacts
- Principal investigator: Diego Raimondo, MD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Study coordinator: Diego Raimondo, MD
- Email: die.raimondo@gmail.com
- Phone: +393290636618
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.