Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)
研究概览
地位
条件
详细说明
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.
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:Ying Cheong
- 电话号码:+44 7977011443
- 邮箱:y.cheong@soton.ac.uk
学习地点
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Southampton、英国、SO16 6YD
- 招聘中
- University Hospital Southampton
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参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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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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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
大体时间: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)
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Ying Cheong、University Hospital Southampton NHS Foundation Trust
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他相关的 MeSH 术语
其他研究编号
- O&G0334
- 362221 (其他标识符:IRAS)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
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