Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Ying Cheong
- 전화번호: +44 7977011443
- 이메일: y.cheong@soton.ac.uk
연구 장소
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Southampton, 영국, so16 6yd
- 모병
- University Hospital Southampton
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Menorrhagia
diagnosed heavy periods with haematin test (>/80ml)
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Normal periods
not diagnosed as heavy with haematin test (<80ml)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
기간: Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)
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Frequency of uterine contractions quantified from cine MRI sequences and compared between participants with heavy menstrual bleeding and controls.
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Cycle 1, Days 18-21 (luteal phase; each cycle is 28 days)
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
기간: Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)
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Dominant frequency (Hz) of uterine bioelectrical signals recorded using wearable pelvic surface electrodes and analysed using frequency-domain methods.
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Cycle 1, Days 18-21 (luteal phase) and Cycle 2 Days 1-5 (menstruation) (each cycle is 28 days)
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Acceptability of wearing device (usability score)
기간: Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
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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).
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Cycle 2, Days 1-5 (menstruation; each cycle is 28 days)
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Molecular markers in endometrial biopsy sample
기간: Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)
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Quantification of molecular biomarkers in endometrial biopsy tissue using histological and molecular analysis techniques (units dependent on biomarker, e.g., pg/mg tissue).
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Cycle 1 (each cycle is 28 days), assessed at Days 1-5 (menstruation) and Days 18-21 (luteal phase)
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Molecular markers in vaginal swab samples
기간: Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)
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Measurement of molecular markers from vaginal swabs using laboratory-based assays.
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Cycle 1, Days 1-5 (menstruation); Days 6-10 (post-menstruation); and Days 18-21 (luteal phase) (each cycle is 28 days)
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Molecular markers in menstrual effluent
기간: Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
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Analysis of biomarkers in menstrual effluent collected during menstruation.
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Cycle 1 (each cycle is 28 days), assessed at Days 1-3 (menstruation)
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Concentration of molecular biomarkers in blood samples
기간: Baseline
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Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).
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Baseline
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공동 작업자 및 조사자
수사관
- 수석 연구원: Ying Cheong, University Hospital Southampton NHS Foundation Trust
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- O&G0334
- 362221 (기타 식별자: IRAS)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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