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Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)

22 april 2026 uppdaterad av: University Hospital Southampton NHS Foundation Trust

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.

Studieöversikt

Status

Rekrytering

Betingelser

Menorragi på grund av godartade orsaker

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

100

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Namn: Ying Cheong
Telefonnummer: +44 7977011443
E-post: y.cheong@soton.ac.uk

Studieorter

Storbritannien
- - Southampton, Storbritannien, SO16 6YD
    - Rekrytering
    - University Hospital Southampton

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

Vuxen

Tar emot friska volontärer

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Antal grupper/kohorter

Kohorter och interventioner

Grupp / Kohort
Menorrhagia diagnosed heavy periods with haematin test (>/80ml)
Normal periods not diagnosed as heavy with haematin test (<80ml)

Vad mäter studien?

Primära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences) Tidsram: 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.	Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)

Sekundära resultatmått

Resultatmått	Åtgärdsbeskrivning	Tidsram
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes Tidsram: 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.	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) Tidsram: 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).	Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
Molecular markers in endometrial biopsy sample Tidsram: 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).	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 Tidsram: 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.	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 Tidsram: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)	Analysis of biomarkers in menstrual effluent collected during menstruation.	Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
Concentration of molecular biomarkers in blood samples Tidsram: Baseline	Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).	Baseline

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University Hospital Southampton NHS Foundation Trust

Samarbetspartners

University of Auckland, New Zealand

Utredare

Huvudutredare: Ying Cheong, University Hospital Southampton NHS Foundation Trust

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 februari 2026

Primärt slutförande (Beräknad)

1 februari 2029

Avslutad studie (Beräknad)

1 februari 2030

Studieregistreringsdatum

Först inskickad

9 mars 2026

Först inskickad som uppfyllde QC-kriterierna

22 april 2026

Första postat (Faktisk)

30 april 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)