Reframing Endometrial Physiology by Advanced Integrated Research (REPAIR)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Ying Cheong
- 電話番号：+44 7977011443
- メール：y.cheong@soton.ac.uk
研究場所
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-
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Southampton、イギリス、so16 6yd
- 募集
- University Hospital Southampton
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参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Frequency of uterine contractions (contractions per minute) measured using cine MRI (HASTE vs TRUFI sequences)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Dominant frequency of uterine bioelectrical activity measured by wearable pelvic electrodes
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
捜査官
- 主任研究者：Ying Cheong、University Hospital Southampton NHS Foundation Trust
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
追加の関連 MeSH 用語
その他の研究ID番号
- O&G0334
- 362221 (その他の識別子：IRAS)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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