Reframing how the uterus works in heavy menstrual bleeding
Reframing Endometrial Physiology by Advanced Integrated Research
This project will try wearable sensors, MRI scans, and blood/tissue samples to find measurable uterine changes linked to heavy menstrual bleeding in people aged 18–45 with and without heavy periods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | University Hospital Southampton NHS Foundation Trust Academic / other |
| Locations | 1 site (Southampton) |
| Trial ID | NCT07557992 on ClinicalTrials.gov |
What this trial studies
This observational study will enroll about 130 participants with and without heavy menstrual bleeding and collect wearable electrophysiology data during menses, pelvic MRI scans, and biosamples. Objective measures of blood loss will be combined with device recordings and imaging to identify physiological signatures of heavy bleeding. Data from two sites will be integrated to look for reproducible patterns in uterine contractility, endometrial repair, and tissue composition. The goal is to generate candidate biomarkers that could support scalable, non-invasive diagnostics.
Who should consider this trial
Good fit: Ideal candidates are people aged 18–45 who have menstrual periods, with or without heavy bleeding, who are not pregnant or breastfeeding and who have not used hormonal treatments in the past two months.
Not a fit: People who are pregnant or breastfeeding, have known uterine malignancy, severe anemia requiring urgent treatment, acute gynecological emergencies, cannot undergo MRI, or cannot provide informed consent are excluded and would not benefit from participation.
Why it matters
Potential benefit: If successful, this work could lead to non-invasive tests using wearables or imaging to diagnose causes of heavy menstrual bleeding and help guide treatment choices.
How similar studies have performed: Elements such as MRI and electrophysiology have shown promising signals in small studies, but combining imaging, wearables, and biosamples for heavy menstrual bleeding is relatively novel and not yet widely validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18-45 * Having Periods Exclusion Criteria: * Currently pregnant or breastfeeding. * Known uterine malignancy, severe anaemia requiring urgent treatment, or other acute gynaecological emergencies. * Inability to undergo MRI (e.g., pacemaker, severe claustrophobia). * Inability to provide informed consent. * Current use of hormonal treatment, or use in the last 2 months
Where this trial is running
Southampton
- University Hospital Southampton — Southampton, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ying Cheong — University Hospital Southampton NHS Foundation Trust
- Study coordinator: Ying Cheong
- Email: y.cheong@soton.ac.uk
- Phone: +44 7977011443
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.