Reproductive Endocrinology Oxford Study (RepOx)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: Female
Minimum Age: 16
Maximum Age: 45
Healthy Volunteers: f
View:

• ● 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

Locations
Other Locations
United Kingdom
Nuffield Department Women's and Reproductive Health
RECRUITING
Oxford
Contact Information
Primary
RepOx Research Midwife
osprea@wrh.ox.ac.uk
++441865 572258
Time Frame
Start Date: 2021-10-21
Estimated Completion Date: 2028-09-01
Participants
Target number of participants: 1175
Treatments
PCOS
No intervention.
PCOS surgery
No intervention
Surgery control
No intervention
IVF PCOS
No intervention
IVF control
No intervention
Investigations, fertility PCOS
No intervention
Investigations, fertility control
No intervention
Pregnancy - gestational diabetes mellitus
No intervention
Pregnancy - Intrahepatic cholestasis of pregnancy
No intervention
Pregnancy - control
No intervention
Sponsors
Collaborators: Bayer, Li Ka Shing Foundation
Leads: University of Oxford

This content was sourced from clinicaltrials.gov