Clinical trial · Observational
Reproductive Endocrinology Oxford Study (RepOx)
NCT05177562CI-TRIAL-00055761RepOxrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is a prospective observational study that aims to identify the underlying mechanisms of PolyCystic Ovarian Syndrome (PCOS) and associated comorbidities such as subfertility, miscarriage; and pregnancy complications such as gestational diabetes mellitus and Intrahepatic cholestasis of pregnancy (ICP). This will be achieved through cross-sectional observation and laboratory analyses.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (10)
- label
- PCOS
- description
- No intervention.
- interventionNames
- Other: No intervention
- label
- PCOS surgery
- description
- No intervention
- interventionNames
- Other: No intervention
- label
- Surgery control
- description
- No intervention
- interventionNames
- Other: No intervention
- label
- IVF PCOS
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 16 Years
- Maximum age
- 45 Years
Show eligibility criteria text
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 HyperprolactinemiaReferences
Publications (0)
Data not yet available
No reference posted for this study.