Reproductive Endocrinology Oxford Study (RepOx)

Recruiting now

Conditions studied: Polycystic Ovary Syndrome

In brief

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.

Key facts

Study ID: NCT05177562
Run by: University of Oxford
People needed: 1175
Starts: 2021-10-21
Expected to finish: 2028-09-01
Last updated by the study team: 2022-01-04

Who can join

Age: 16 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

● 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

You may not qualify if…

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

Where it is running

Nuffield Department Women's and Reproductive Health — Oxford, Oxfordshire, United Kingdom (enrolling)

Full record on ClinicalTrials.gov

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