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Идёт набор NCT05177562

Reproductive Endocrinology Oxford Study (RepOx)

— Наблюдательное Polycystic Ovary Syndrome

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: No intervention.
Кому может быть актуально
Состояния в реестре: Polycystic Ovary Syndrome. Базовые параметры: 16 лет — 45 лет · Женщины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Великобритания
Следующий шаг
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Обзор

This is a prospective observational study that aims to identify the underlying mechanisms of PolyCystic Ovarian Syndrome (PCOS) and associated comorbidities such as subfertility, miscarriage; and pregnancy complications such as gestational diabetes mellitus and Intrahepatic cholestasis of pregnancy (ICP). This will be achieved through cross-sectional observation and laboratory analyses.

Подробное описание

Here we propose a comprehensive program to dissect the underlying disease-causing mechanisms of PCOS and associated comorbidities. We will investigate how the different layers of biological information (ranging from DNA variant genotyping, to RNA sequencing and proteomics), and clinical characteristics are correlated with each other and how this affects PCOS in fat tissue derived cells, as well as ovarian tissue and tissue derived cells by using a combination of big data analysis, a range of "-omics" technologies, of both in-house generated and publicly available data, paired with state of the art statistical and bioinformatics analysis. Out of these mechanisms and pathways we will identify druggable targets for proposals for detailed functional follow up with an aim of development of novel therapeutic options for PCOS.

Вмешательства

  • Другое No intervention
    There is no intervention in this study

Первичные конечные точки

  • Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes [Срок оценки: one visit]
Вторичные конечные точки (4)
  • To identify novel biomarkers of PCOS and associated comorbidities. [Срок оценки: one visit]
  • To identify clinical subgroups of PCOS and associated comorbidities. [Срок оценки: one visit]
  • To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways [Срок оценки: one visit]
  • To identify novel drug targets, develop models of disease progression and prediction. [Срок оценки: one visit]

Критерии участия

Критерии включения

  • ● General Criteria for all groups
  • Participant is willing and able to give informed consent for participation in the study.
  • Female, aged between 16 and 45 years of age. As IVF is not undertaken in women less that 18 years, this group will between 18 and 45 years o

● PCOS (Group 1, 2 and 3)

  • Currently under investigation for or having diagnosis of PCOS having displayed one or more of the following: Hyperandrogenism, Ovulation Dysfunction and Polycystic ovaries on ultrasound (known as the Rotterdam criteria)

● PCOS Controls (Group 4 and 5)

  • Patients under gynaecological investigation or having assisted reproduction
  • Exhibit no features of PCOS

● Miscarriage Group (Group 6)

  • Have had at least two previous miscarriages
  • Recruited at any time after their second menstrual cycle following a miscarriage

● Miscarriage Controls (Group 7)

  • Patients will have had zero or no more than one miscarriage and having fertility investigations.

● Pregnant GDM (Group 8)

  • Pregnant women at least 28 weeks gestation with :
  • 1\) A fasting plasma glucose of 5.1mmol/L or above or
  • 2\) A 1 hr plasma glucose of 10mmol/L or
  • 3\) A 2-hr plasma glucose level of 8.5mmol/L or above

● Pregnant ICP (Group 9)

  • Women at least 28 weeks gestation with :
  • Raised ALT or raised bile acids in the context of pruritus with no rash
  • ALT (>32iu/l) and bile acids (>14micromol/l) Pregnant Control (Group 10)
  • Pregnant women at least 28 weeks gestation with no diagnosis of GDM or ICP

Критерии исключения

  • For all groups - The participant may not enter the study if ANY of the following apply.
  • Unable to read, or to understand written or spoken English
  • Currently involved in any Clinical Trial of an Investigational Medicinal Product (CTIMP)
  • Undergoing surgery because of a possible cancer diagnosis
  • Diagnosis of other androgen excess disorders such as Congenital Adrenal Hyperplasia (CAH), Androgen Secreting tumours, Cushing syndrome, or Hyperprolactinemia

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Великобритания · 1 центр
  • Nuffield Department Women's and Reproductive Health — Oxford

Идентификаторы

NCT: NCT05177562 · IRAS302159

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗