No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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At a Glance
Age
16 – 45
Sex
Female
Study type
Observational
Participants needed
1,175 (estimated)
Sponsor
University of Oxford · Other
Who this trial is looking for
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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.
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Eligibility Criteria
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
…
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
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