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NCT Number: NCT07557992

Reframing Endometrial Physiology by Advanced Integrated Research

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.

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Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

University Hospital Southampton

Southampton, so16 6yd, United Kingdom

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

    Dominant frequency (Hz) of uterine bioelectrical signals recorded using wearable pelvic surface electrodes and analysed using frequency-domain methods.

  2. Acceptability of wearing device (usability score)

    Time frame: Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)

    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).

  3. 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)

    Quantification of molecular biomarkers in endometrial biopsy tissue using histological and molecular analysis techniques (units dependent on biomarker, e.g., pg/mg tissue).

  4. 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)

    Measurement of molecular markers from vaginal swabs using laboratory-based assays.

  5. Molecular markers in menstrual effluent

    Time frame: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)

    Analysis of biomarkers in menstrual effluent collected during menstruation.

  6. Concentration of molecular biomarkers in blood samples

    Time frame: Baseline

    Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).

Study contacts

Contact information is provided by the study sponsor or research team.

Ying Cheong

CONTACT

[email protected]

+44 7977011443

Sponsors and collaborators

Lead sponsor

University Hospital Southampton NHS Foundation Trust

Other

Collaborators

  • University of Auckland, New Zealand

Registry information

Acronym: REPAIR

Important dates

Study start
2026
Primary completion
2029
Study completion
2030
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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