Understanding the causes of Polycystic Ovary Syndrome
Reproductive Endocrinology Oxford Study (RepOx)
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 |
|---|---|
| Enrollment | 1175 (estimated) |
| Ages | 16 Years to 45 Years |
| Sex | Female |
| Sponsor | University of Oxford Academic / other |
| Locations | 1 site (Oxford, Oxfordshire) |
| Trial ID | NCT05177562 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include females aged 16 to 45 with a diagnosis of PCOS or those experiencing related reproductive challenges.
Not a fit: Patients who do not have PCOS or related reproductive issues may not benefit from this study.
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 performed: Other studies have shown promise in understanding PCOS through similar biological and observational approaches, but this study aims to provide a more comprehensive analysis.
Eligibility criteria
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 this trial is running
Oxford, Oxfordshire
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.