Reproductive Endocrinology Oxford Study (RepOx)

Summary

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.

Eligibility

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

Conditions2

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