Reproductive Endocrinology Oxford Study (RepOx)
Recruiting · NCT05177562 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Oxford
View the official record on ClinicalTrials.gov →Interventions studied
No intervention
What this trial is about
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.
Who can take part
Age range
16 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
1 location listed.
- Nuffield Department Women's and Reproductive Health - Oxford, Oxfordshire, United Kingdom