Understanding the causes of Polycystic Ovary Syndrome
Official title: Reproductive Endocrinology Oxford Study (RepOx)
Run by University of Oxford · NCT05177562 · Data updated 2026-11-12
This study is trying to understand what causes Polycystic Ovary Syndrome (PCOS) and its related problems to find new treatment options for women with PCOS and reproductive issues.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 16 Years to 45 Years |
| Sex | Women only |
| Enrollment | 1175 (estimated) |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Status | Recruiting |
| Started | October 21, 2021 |
| Main results expected | September 1, 2028 |
| Study ends | September 1, 2028 |
| Registry record updated | January 4, 2022 |
| Trial ID | NCT05177562 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include females aged 16 to 45 with a diagnosis of PCOS or those experiencing related reproductive challenges.
✕Probably not a fit
Patients who do not have PCOS or related reproductive issues may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to explore the underlying mechanisms of Polycystic Ovary Syndrome (PCOS) and its related complications, such as subfertility and pregnancy issues. By utilizing a combination of biological data analysis, including DNA genotyping, RNA sequencing, and proteomics, the study will correlate clinical characteristics with biological information. The goal is to identify potential drug targets for developing new therapeutic options for PCOS. Participants will include women diagnosed with PCOS and those with related reproductive issues.
Why it matters
Potential benefit: If successful, this study could lead to new treatments for women suffering from PCOS and its associated complications.
How similar studies have gone: Other studies have shown promise in understanding PCOS through similar biological and observational approaches, but this study aims to provide a more comprehensive analysis.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Nuffield Department Women's and Reproductive Health
Oxford, Oxfordshire, United Kingdom Recruiting
Study contacts
- Study coordinator: RepOx Research Midwife
- Email: osprea@wrh.ox.ac.uk
- Phone: ++441865 572258
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Precision acupuncture and lifestyle for PCOS
This trial tests whether a precision acupuncture approach combined with a personalized lifestyle plan helps improve insulin resistance in people with PCOS compared with conventional acupuncture and standard lifestyle changes.
-
Orlistat for metabolic and hormonal features in women with PCOS
This trial tests whether adding orlistat to lifestyle advice helps improve metabolic and hormonal aspects in women with PCOS compared to lifestyle advice alone.
-
Physical activity program for women with PCOS and fatty pancreas plus subclinical hypothyroidism
A program of exercise is being tested to see if it helps women with PCOS who also have fatty pancreas and subclinical hypothyroidism, compared to usual care.
-
Glucose monitoring in women with polycystic ovary syndrome
This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.
-
Adding regular exercise to a low‑calorie diet and metformin for women with PCOS and asthma
This study will test whether adding regular treadmill walking to a low‑calorie diet and daily metformin helps women who have both PCOS and asthma.
-
Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women
We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.