Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
1175 participants
OBSERVATIONAL
2021-10-21
2028-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
REFUEL PCOS Study 1
NCT05973175
Compromised Microcirculation in Women With Polycystic Ovary Syndrome
NCT00757185
The RolE oF Androgen Excess in MUscle Energy MetaboLism in Women With PolyCystic Ovary Syndrome (REFUEL PCOS) Study 2
NCT05647356
The PCOS Challenge Study
NCT05797909
Development of a Structured Education Programme for Women With Polycystic Ovary Syndrome
NCT01462864
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PCOS
No intervention.
No intervention
There is no intervention in this study
PCOS surgery
No intervention
No intervention
There is no intervention in this study
Surgery control
No intervention
No intervention
There is no intervention in this study
IVF PCOS
No intervention
No intervention
There is no intervention in this study
IVF control
No intervention
No intervention
There is no intervention in this study
Investigations, fertility PCOS
No intervention
No intervention
There is no intervention in this study
Investigations, fertility control
No intervention
No intervention
There is no intervention in this study
Pregnancy - gestational diabetes mellitus
No intervention
No intervention
There is no intervention in this study
Pregnancy - Intrahepatic cholestasis of pregnancy
No intervention
No intervention
There is no intervention in this study
Pregnancy - control
No intervention
No intervention
There is no intervention in this study
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
No intervention
There is no intervention in this study
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
16 Years
45 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Bayer
INDUSTRY
Li Ka Shing Foundation
OTHER
University of Oxford
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nuffield Department Women's and Reproductive Health
Oxford, Oxfordshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IRAS302159
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.