Reproductive Endocrinology Oxford Study (RepOx)

Launched by UNIVERSITY OF OXFORD · Dec 15, 2021

Keywords

ClinConnect Summary

The Reproductive Endocrinology Oxford Study (RepOx) is an important research project focused on understanding Polycystic Ovary Syndrome (PCOS) and related issues such as difficulties in getting pregnant, miscarriages, and complications during pregnancy like gestational diabetes. The study aims to explore the underlying reasons for these conditions by observing participants and conducting laboratory tests. If you are a woman aged between 16 and 45 and have been diagnosed with PCOS or are experiencing fertility challenges, you may be eligible to join this study.

Participants can expect to take part in detailed observations and tests that help researchers learn more about PCOS and its effects. The study is currently recruiting women who fit specific criteria, such as those with diagnosed PCOS, women who have experienced multiple miscarriages, or pregnant women facing specific health concerns. It’s important to note that participants should be able to understand and communicate in English and not be involved in other clinical trials or have certain medical conditions. By participating, you will contribute to valuable research that could improve understanding and treatment options for PCOS and its related challenges.

Gender

FEMALE

Eligibility criteria

• 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