Actively Recruiting
Reproductive Endocrinology Oxford Study (RepOx)
Led by University of Oxford · Updated on 2022-01-04
1175
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
U
University of Oxford
Lead Sponsor
B
Bayer
Collaborating Sponsor
AI-Summary
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.
CONDITIONS
Official Title
Reproductive Endocrinology Oxford Study (RepOx)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant is willing and able to give informed consent for participation in the study.
- Female, aged between 16 and 45 years of age.
- For PCOS groups: Currently under investigation for or diagnosed with PCOS showing one or more of hyperandrogenism, ovulation dysfunction, or polycystic ovaries on ultrasound (Rotterdam criteria).
- For PCOS controls: Undergoing gynecological investigation or assisted reproduction with no PCOS features.
- For miscarriage group: Had at least two previous miscarriages and recruited after their second menstrual cycle following a miscarriage.
- For miscarriage controls: Had zero or no more than one miscarriage and undergoing fertility investigations.
- For pregnant gestational diabetes mellitus group: Pregnant women at least 28 weeks gestation with fasting plasma glucose ≥5.1 mmol/L, or 1-hour plasma glucose ≥10 mmol/L, or 2-hour plasma glucose ≥8.5 mmol/L.
- For pregnant intrahepatic cholestasis of pregnancy group: Women at least 28 weeks gestation with raised ALT (>32 iu/l) or bile acids (>14 micromol/l) and pruritus without rash.
- For pregnant controls: Pregnant women at least 28 weeks gestation with no diagnosis of gestational diabetes mellitus or intrahepatic cholestasis of pregnancy.
You will not qualify if you...
- Unable to read or understand written or spoken English.
- Currently involved in any clinical trial of an investigational medicinal product.
- Undergoing surgery due to possible cancer diagnosis.
- Diagnosed with other androgen excess disorders such as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing syndrome, or hyperprolactinemia.
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nuffield Department Women's and Reproductive Health
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Actively Recruiting
Research Team
R
RepOx Research Midwife
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
10
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