Polycystic Ovary SyndromeRepOxNCT05177562
Reproductive Endocrinology Oxford Study (RepOx)
An observational study of Polycystic Ovary Syndrome, run by University of Oxford at 1 site in United Kingdom.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 16 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 1,175 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Oct 2021to 1 Sep 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 45 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Women with and without OCOS and known associated phenotypes
Who may be able to join
- ● 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)
Show all 23Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Nuffield Department Women's and Reproductive Health
Oxford, Oxfordshire, OX3 9DU
OSPREA -Study Research Midwives, +44 1865 572258, OSPREA@wrh.ox.ac.uk
Ingrid Granne, MD
About this study
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.
Read the detailed description
Here we propose a comprehensive program to dissect the underlying disease-causing mechanisms of PCOS and associated comorbidities. We will investigate how the different layers of biological information (ranging from DNA variant genotyping, to RNA sequencing and proteomics), and clinical characteristics are correlated with each other and how this affects PCOS in fat tissue derived cells, as well as ovarian tissue and tissue derived cells by using a combination of big data analysis, a range of "-omics" technologies, of both in-house generated and publicly available data, paired with state of the art statistical and bioinformatics analysis. Out of these mechanisms and pathways we will identify druggable targets for proposals for detailed functional follow up with an aim of development of novel therapeutic options for PCOS.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- No intervention
- Keywords
- PCOS
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
There is no intervention in this study
| Study group | Role | What they receive |
|---|---|---|
| PCOS | No intervention. Receives: Other: No intervention | |
| PCOS surgery | No intervention Receives: Other: No intervention | |
| Surgery control | No intervention Receives: Other: No intervention | |
| IVF PCOS | No intervention Receives: Other: No intervention | |
| IVF control | No intervention Receives: Other: No intervention | |
| Investigations, fertility PCOS | No intervention Receives: Other: No intervention | |
| Investigations, fertility control | No intervention Receives: Other: No intervention | |
| Pregnancy - gestational diabetes mellitus | No intervention Receives: Other: No intervention | |
| Pregnancy - Intrahepatic cholestasis of pregnancy | No intervention Receives: Other: No intervention | |
| Pregnancy - control | No intervention Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes
Questionnaire data, imaging analysis, medical records and sample analysis
Measured: one visit
Secondary outcomes (4)
To identify novel biomarkers of PCOS and associated comorbidities.
Measured: one visit
To identify clinical subgroups of PCOS and associated comorbidities.
Measured: one visit
To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways
Measured: one visit
To identify novel drug targets, develop models of disease progression and prediction.
Measured: one visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start21 Oct 2021
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,175 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Bayer, Li Ka Shing Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05177562
- Sponsor's protocol ID
- IRAS302159
- Acronym
- RepOx
- Status last verified
- Dec 2021
- First submitted
- 15 Dec 2021
- Last updated
- 4 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reproductive Endocrinology Oxford Study (RepOx)
- ClinicalTrials.gov ID
- NCT05177562
- Acronym / sponsor ID
- RepOx / IRAS302159
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,175 participants (estimated)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Bayer, Li Ka Shing Foundation
- Study start
- 21 Oct 2021 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Here we propose a comprehensive program to dissect the underlying disease-causing mechanisms of PCOS and associated comorbidities. We will investigate how the different layers of biological information (ranging from DNA variant genotyping, to RNA sequencing and proteomics), and clinical characteristics are correlated with each other and how this affects PCOS in fat tissue derived cells, as well as ovarian tissue and tissue derived cells by using a combination of big data analysis, a range of "-omics" technologies, of both in-house generated and publicly available data, paired with state of the art statistical and bioinformatics analysis. Out of these mechanisms and pathways we will identify druggable targets for proposals for detailed functional follow up with an aim of development of novel therapeutic options for PCOS.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| PCOS | – | Other: No interventionNo intervention. |
| PCOS surgery | – | Other: No interventionNo intervention |
| Surgery control | – | Other: No interventionNo intervention |
| IVF PCOS | – | Other: No interventionNo intervention |
| IVF control | – | Other: No interventionNo intervention |
| Investigations, fertility PCOS | – | Other: No interventionNo intervention |
| Investigations, fertility control | – | Other: No interventionNo intervention |
| Pregnancy - gestational diabetes mellitus | – | Other: No interventionNo intervention |
| Pregnancy - Intrahepatic cholestasis of pregnancy | – | Other: No interventionNo intervention |
| Pregnancy - control | – | Other: No interventionNo intervention |
Who may qualify
- Ages
- 16 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Women with and without OCOS and known associated phenotypes
Key inclusion criteria (23 listed)
- ● General Criteria for all groups
- ● PCOS (Group 1, 2 and 3)
- ● PCOS Controls (Group 4 and 5)
- ● Miscarriage Group (Group 6)
- ● Miscarriage Controls (Group 7)
Key exclusion criteria (5 listed)
- For all groups - The participant may not enter the study if ANY of the following apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionThere is no intervention in this study | Other | IVF PCOS, IVF control, Investigations, fertility PCOS, Investigations, fertility control, PCOS, PCOS surgery, Pregnancy - Intrahepatic cholestasis of pregnancy, Pregnancy - control, Pregnancy - gestational diabetes mellitus, Surgery control |
Primary outcome
Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes
Time frame: one visit
Questionnaire data, imaging analysis, medical records and sample analysis
4 secondary outcomes
To identify novel biomarkers of PCOS and associated comorbidities.
Time frame: one visit
To identify clinical subgroups of PCOS and associated comorbidities.
Time frame: one visit
To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways
Time frame: one visit
To identify novel drug targets, develop models of disease progression and prediction.
Time frame: one visit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Polycystic Ovary Syndrome
Not yet recruitingObservational study
Chinese Overweight/Obesity Cohort: Metabolic & Comorbidity Risks
Obesity & Overweight, Diabetes Mellitus, Type 2
RecruitingPhase 1
Safety of Cultured Allogeneic Adult Umbilical Cord or Placental Derived Mesenchymal Stem Cells for PCOS
Polycystic Ovary Syndrome (PCOS), Polycystic Ovary Syndrome
Active, not recruiting
The Effect of Lifestyle Program Women With PCOS
Polycystic Ovary Syndrome
Not yet recruiting
Time-Restricted Eating as a Dietary Intervention for Polyendocrine Metabolic Ovarian Syndrome (PMOS): Protocol for a Randomized Controlled Trial
Polycystic Ovary Syndrome
Enrolling by invitation
Nutrition Intervention for Women With Polycystic Ovary Syndrome
PCOS- Polycystic Ovary Syndrome, Nutrition Intervention
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact RepOx Research Midwife (++441865 572258, osprea@wrh.ox.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes (time frame: one visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2022.