Reproductive Endocrinology Oxford Study (RepOx) (RepOx)
研究概览
详细说明
研究类型
注册 (预期的)
联系人和位置
学习联系方式
- 姓名:RepOx Research Midwife
- 电话号码:++441865 572258
- 邮箱:osprea@wrh.ox.ac.uk
学习地点
-
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Oxfordshire
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Oxford、Oxfordshire、英国、OX3 9DU
- 招聘中
- Nuffield Department Women's and Reproductive Health
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接触:
- OSPREA -Study Research Midwives
- 电话号码:+44 1865 572258
- 邮箱:OSPREA@wrh.ox.ac.uk
-
首席研究员:
- Ingrid Granne, MD
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
● 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
Exclusion Criteria:
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
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 |
干预/治疗 |
---|---|
PCOS
No intervention.
|
本研究没有干预
|
PCOS surgery
No intervention
|
本研究没有干预
|
Surgery control
No intervention
|
本研究没有干预
|
IVF PCOS
No intervention
|
本研究没有干预
|
IVF control
No intervention
|
本研究没有干预
|
Investigations, fertility PCOS
No intervention
|
本研究没有干预
|
Investigations, fertility control
No intervention
|
本研究没有干预
|
Pregnancy - gestational diabetes mellitus
No intervention
|
本研究没有干预
|
Pregnancy - Intrahepatic cholestasis of pregnancy
No intervention
|
本研究没有干预
|
Pregnancy - control
No intervention
|
本研究没有干预
|
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 |
---|---|---|
Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes
大体时间:one visit
|
Questionnaire data, imaging analysis, medical records and sample analysis
|
one visit
|
次要结果测量
结果测量 |
大体时间 |
---|---|
To identify novel biomarkers of PCOS and associated comorbidities.
大体时间:one visit
|
one visit
|
To identify clinical subgroups of PCOS and associated comorbidities.
大体时间:one visit
|
one visit
|
To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways
大体时间:one visit
|
one visit
|
To identify novel drug targets, develop models of disease progression and prediction.
大体时间:one visit
|
one visit
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (预期的)
研究完成 (预期的)
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
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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