Clinical trial Recruiting at 1 site Observational Ages 16 to 45 Women only

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.

More Polycystic Ovary Syndrome trials

Quick facts

Study typeObservational
Ages16 Years to 45 Years
SexWomen only
Enrollment1175 (estimated)
SponsorUniversity of Oxford
Academic / other
Locations1 site (Oxford, Oxfordshire)
StatusRecruiting
StartedOctober 21, 2021
Main results expectedSeptember 1, 2028
Study endsSeptember 1, 2028
Registry record updatedJanuary 4, 2022
Trial IDNCT05177562 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.