NCT05177562Recruiting
Reproductive Endocrinology Oxford Study (RepOx)
Source: ClinicalTrials.gov · Last updated 4 Jan 2022 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1175 (estimated)
- First submitted
- 15 Dec 2021
- Start date
- 21 Oct 2021
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- University of Oxford
- NCT number
- NCT05177562
What you commit to
- Study type: Observational
- Planned participants: 1175
- From 21 Oct 2021 to the primary completion date, 1 Sept 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- ● 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
Age in the registry: 16 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Nuffield Department Women's and Reproductive Health Coordinator of this site? Confirm its status | Oxford | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.