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Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)

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.

研究概览

地位

招聘中

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

观察性的

注册 (估计的)

100

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

学习地点

      • Southampton、英国、SO16 6YD
        • 招聘中
        • University Hospital Southampton

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

取样方法

非概率样本

研究人群

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.

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

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

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
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)
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)

次要结果测量

结果测量
措施说明
大体时间
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)
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)
大体时间: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
大体时间: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
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)
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
大体时间: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
大体时间:Baseline
Measurement of circulating biomarkers in peripheral blood samples using laboratory assays (units dependent on biomarker, e.g., pg/mL).
Baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Ying Cheong、University Hospital Southampton NHS Foundation Trust

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年2月6日

初级完成 (估计的)

2029年2月1日

研究完成 (估计的)

2030年2月1日

研究注册日期

首次提交

2026年3月9日

首先提交符合 QC 标准的

2026年4月22日

首次发布 (实际的)

2026年4月30日

研究记录更新

最后更新发布 (实际的)

2026年4月30日

上次提交的符合 QC 标准的更新

2026年4月22日

最后验证

2026年3月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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