RecruitingOBSERVATIONAL

Reproductive Endocrinology Oxford Study (RepOx)

The Reproductive Endocrinology Oxford Study (RepOx) aims to understand why Polycystic Ovary Syndrome (PCOS) happens and how it leads to other health issues. These issues can include difficulties getting pregnant, miscarriages, and pregnancy problems like gestational diabetes and a liver condition called ICP. Researchers will collect information from women with and without PCOS, including their health details and biological samples. By looking closely at genetic information and other factors, they hope to find the root causes of PCOS. This knowledge could help in developing new treatments for PCOS in the future. The study does not involve any new medicines or treatments; it's purely about observing and learning.

At a glance

Status

Recruiting

Sponsor

University of Oxford

Enrolment target

1,175

Start

21 Oct 2021

Estimated completion

01 Sep 2028

Polycystic Ovary Syndrome

What is this study about?

Imagine you have a puzzle, but you don't have all the pieces. That's a bit like Polycystic Ovary Syndrome (PCOS) for doctors and researchers right now. We know it affects many women, causing a variety of symptoms and sometimes making it harder to have a baby or leading to complications during pregnancy. But we don't fully understand all the reasons why it happens.

This study, called RepOx, is like a big detective project. Researchers want to gather lots of clues from women with PCOS and women who don't have it. They'll look at things like your health history and samples like blood or tissue. By examining these clues very closely, including tiny details from your DNA and cells, they hope to piece together the puzzle of PCOS. They want to see how different biological information connects with your health.

The main goal is to find the fundamental ways PCOS start and how it can lead to other issues like having trouble getting pregnant, experiencing miscarriages, or developing pregnancy problems such as diabetes during pregnancy or a liver condition called ICP (Intrahepatic Cholestasis of Pregnancy). By understanding these underlying causes better, the hope is to identify new ways doctors could treat PCOS in the future, offering better options for women.

Key takeaways

Aims to understand why PCOS happens and causes related health issues.
It's an 'observational study' – no new treatments involved.
Researchers will collect health information and samples like blood.
Could help develop new PCOS treatments in the future.
You can withdraw at any time without affecting your usual care.
Eligible women are aged 16-45, with or without PCOS, miscarriages, or specific pregnancy conditions.

Who may be eligible?

The RepOx study is looking for women aged 16 to 45 years old. This includes women who have been diagnosed with PCOS or are currently being checked for it. They're also looking for women who do not have PCOS but are having checks for gynaecological reasons or are trying to get pregnant with medical help.

The study also includes specific groups of women. This includes those who have had two or more miscarriages, as well as women who are pregnant (at least 28 weeks along) and have been diagnosed with gestational diabetes or a liver condition called ICP. Finally, they need pregnant women without these conditions to compare against.

There are some reasons why you wouldn't be able to join. For example, if you can't read or understand English, or if you're currently taking part in another medical trial involving a new medication. Also, if you're about to have surgery because of a possible cancer diagnosis, or if you have certain other hormone conditions similar to PCOS, you wouldn't be able to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman between 16 and 45 years old?
Do you have PCOS, are you being checked for it, or are you having gynaecological investigations?
Are you pregnant (at least 28 weeks) with gestational diabetes or ICP, or without these conditions?
Can you read and understand English?
Are you NOT currently part of another drug trial?
Are you NOT about to have surgery for a possible cancer diagnosis?

Answer every question to see your result.

What does participation involve?

This study is an 'observational' study. This means you won't be given any new medications or treatments. Instead, researchers will learn by observing your health and collecting information and samples. You'll likely have some visits to the research clinic in Oxford where researchers will collect health information and potentially samples like blood, or tissue if you are already having a gynaecological procedure. The specific assessments and visits will depend on which group you fit into (e.g., if you have PCOS, have had miscarriages, or are pregnant). The total duration of your involvement will also depend on your specific group but typically involves a limited number of visits and no long-term follow-up beyond the study aims.

Potential risks and benefits

Participating in this study might not directly benefit your health immediately, as it's focused on research and understanding PCOS better, rather than providing a new treatment. However, the information gathered could greatly help future generations of women with PCOS by leading to new and better treatments. Risks are generally low, mainly involving the minor discomfort of blood tests or having tissue samples taken if you're already undergoing a procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Nuffield Department Women's and Reproductive Health
Verified postcode
Oxford, United Kingdom· Recruiting

Common questions

What is an 'observational study'?

It means researchers will collect information and learn from it, but you won't be given any new medicines or treatments as part of the study.

Will this study offer me a new treatment for PCOS?

No, this study is about understanding PCOS better, not giving new treatments. The aim is to help develop future treatments.

Will I have to take any medication?

No, this study does not involve taking any new medications.

How long will I be involved in the study?

The length of your involvement will depend on which group you are in, but it generally involves a few visits and no long-term follow-up.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time without having to give a reason, and it won't affect your medical care.

How to find out more

RepOx Research Midwife

osprea@wrh.ox.ac.uk ++441865 572258 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.