Menorrhagia Due to Benign CausesREPAIRNCT07557992
Reframing Endometrial Physiology by Advanced Integrated Research
An observational study of Menorrhagia Due to Benign Causes, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Menorrhagia Due to Benign Causes
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Feb 2026to 1 Feb 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited from in and around Hampshire with the ability to attend Southampton General Hospital for appointments. They will be recruited from both within hospital settings but also the community as many women suffer with HMB without seeking support.
Who may be able to join
- 18-45
- Having Periods
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospital Southampton
Southampton, so16 6yd
About this study
Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.
Read the detailed description
Heavy menstrual bleeding (HMB) affects up to one-third of women of reproductive age, with a greater prevalence than asthma or diabetes, yet it remains under-recognised and undertreated. HMB is both a symptom and a potential signal of underlying reproductive or systemic dysfunction, including coagulopathies, vascular fragility, inflammation, and abnormal uterine contractility. Its impact is profound, physically, emotionally, and socioeconomically, but current diagnostic practice relies heavily on subjective reporting.
Objective assessment of blood loss is possible with the alkaline haematin test, the gold standard, but it is rarely used in clinical settings due to logistical barriers. This has led to misclassification in research and clinical care, limiting progress in understanding the mechanisms of HMB. Emerging evidence suggests that subtle abnormalities in uterine peristalsis, endometrial repair, and tissue composition may be detectable with advanced imaging and electrophysiology.
The REPAIR study addresses this by integrating anatomical (MRI), functional (wearable electrophysiology), and biological (biosample analysis) measures in women with and without objectively confirmed HMB. This approach aims to establish reproducible physiological signatures that could form the basis of scalable, non-invasive diagnostics.
- Conditions
- Menorrhagia Due to Benign Causes
- Keywords
- menorrrhagia, heavy menstrual bleeding, electrophysiology, uterine contractility
- Medical subject headings
- Menorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Menorrhagia | diagnosed heavy periods with haematin test (>/80ml) | |
| Normal periods | not diagnosed as heavy with haematin test (<80ml) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.
Measured: Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)
Secondary outcomes (6)
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
Dominant frequency (Hz) of uterine bioelectrical signals recorded using wearable pelvic surface electrodes and analysed using frequency-domain methods.
Measured: Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)
Acceptability of wearing device (usability score)
Participant-reported usability and acceptability assessed using a structured usability questionnaire developed for this study, comprising 9 items with ordinal response scales. Responses will be assigned numerical values and summed to generate a composite usability score (range 9-36, with higher scores indicating greater acceptability).
Measured: Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
Molecular markers in endometrial biopsy sample
Quantification of molecular biomarkers in endometrial biopsy tissue using histological and molecular analysis techniques (units dependent on biomarker, e.g., pg/mg tissue).
Measured: Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)
Molecular markers in vaginal swab samples
Measurement of molecular markers from vaginal swabs using laboratory-based assays.
Measured: Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)
Molecular markers in menstrual effluent
Analysis of biomarkers in menstrual effluent collected during menstruation.
Measured: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
Concentration of molecular biomarkers in blood samples
Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start6 Feb 2026
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Menorrhagia Due to Benign CausesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Responsible party
- Sponsor
- Investigators
- Ying Cheong, Principal investigator, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07557992
- Sponsor's protocol ID
- O&G0334
- Other IDs
- 362221
- Acronym
- REPAIR
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reframing Endometrial Physiology by Advanced Integrated Research
- ClinicalTrials.gov ID
- NCT07557992
- Acronym / sponsor ID
- REPAIR / O&G0334
- Conditions
- Menorrhagia Due to Benign Causes
- Keywords
- menorrrhagia, heavy menstrual bleeding, electrophysiology, uterine contractility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Auckland, New Zealand
- Study start
- 6 Feb 2026 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Heavy menstrual bleeding (HMB) affects 1 in 3 women and can significantly impact quality of life. Despite its prevalence, there is no accessible and accurate diagnostic test. This research will use wearable sensors, magnetic resonance imaging (MRI) scans, and biological sample collection to identify changes in the uterus linked with HMB. The investigators aim to recruit approximately 130 participants across two study sites over three years, including people with and without HMB.
Detailed description
Heavy menstrual bleeding (HMB) affects up to one-third of women of reproductive age, with a greater prevalence than asthma or diabetes, yet it remains under-recognised and undertreated. HMB is both a symptom and a potential signal of underlying reproductive or systemic dysfunction, including coagulopathies, vascular fragility, inflammation, and abnormal uterine contractility. Its impact is profound, physically, emotionally, and socioeconomically, but current diagnostic practice relies heavily on subjective reporting.
Objective assessment of blood loss is possible with the alkaline haematin test, the gold standard, but it is rarely used in clinical settings due to logistical barriers. This has led to misclassification in research and clinical care, limiting progress in understanding the mechanisms of HMB. Emerging evidence suggests that subtle abnormalities in uterine peristalsis, endometrial repair, and tissue composition may be detectable with advanced imaging and electrophysiology.
The REPAIR study addresses this by integrating anatomical (MRI), functional (wearable electrophysiology), and biological (biosample analysis) measures in women with and without objectively confirmed HMB. This approach aims to establish reproducible physiological signatures that could form the basis of scalable, non-invasive diagnostics.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Menorrhagia | – | –diagnosed heavy periods with haematin test (>/80ml) |
| Normal periods | – | –not diagnosed as heavy with haematin test (<80ml) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited from in and around Hampshire with the ability to attend Southampton General Hospital for appointments. They will be recruited from both within hospital settings but also the community as many women suffer with HMB without seeking support.
Key inclusion criteria (2 listed)
- 18-45
- Having Periods
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
Time frame: Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)
Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.
6 secondary outcomes
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
Time frame: Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)
Acceptability of wearing device (usability score)
Time frame: Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
Molecular markers in endometrial biopsy sample
Time frame: Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)
Molecular markers in vaginal swab samples
Time frame: Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)
Molecular markers in menstrual effluent
Time frame: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
Concentration of molecular biomarkers in blood samples
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ying Cheong principal investigator
University Hospital Southampton NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Menorrhagia Due to Benign Causes, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ying Cheong (+44 7977011443, y.cheong@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences) (time frame: Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.