Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)
22. april 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret beskrivelse
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.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
100
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ying Cheong
- Telefonnummer: +44 7977011443
- E-mail: y.cheong@soton.ac.uk
Studiesteder
-
-
-
Southampton, Det Forenede Kongerige, so16 6yd
- Rekruttering
- University Hospital Southampton
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ja
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
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.
Beskrivelse
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
|---|
|
Menorrhagia
diagnosed heavy periods with haematin test (>/80ml)
|
|
Normal periods
not diagnosed as heavy with haematin test (<80ml)
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
Tidsramme: 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)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Baseline
|
Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).
|
Baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Ying Cheong, University Hospital Southampton NHS Foundation Trust
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
6. februar 2026
Primær færdiggørelse (Anslået)
1. februar 2029
Studieafslutning (Anslået)
1. februar 2030
Datoer for studieregistrering
Først indsendt
9. marts 2026
Først indsendt, der opfyldte QC-kriterier
22. april 2026
Først opslået (Faktiske)
30. april 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. april 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2026
Sidst verificeret
1. marts 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Urogenitale sygdomme
- Genitale sygdomme
- Patologiske processer
- Urogenitale sygdomme hos kvinder
- Kvinders urogenitale sygdomme og graviditetskomplikationer
- Livmodersygdomme
- Kønssygdomme, kvindelige
- Blødning
- Livmoderblødning
- Menstruationsforstyrrelser
- Patologiske tilstande, tegn og symptomer
- Menorrhagia
Andre undersøgelses-id-numre
- O&G0334
- 362221 (Anden identifikator: IRAS)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .