Reproductive Endocrinology Oxford Study (RepOx)

NCT05177562 | Recruiting

• 1 other identifier: IRAS302159
• Study Type: observational
• Target: 1,175
• Locations: 1 country
• Sites: 1

Brief 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). This will be achieved through cross-sectional observation and laboratory analyses.

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS

Outcome Measures

Primary Outcomes (1)

• Identify the underlying genetic and pathophysiological mechanisms of PCOS and associated phenotypes

  Questionnaire data, imaging analysis, medical records and sample analysis

  one visit

Secondary Outcomes (4)

• To identify novel biomarkers of PCOS and associated comorbidities.

  one visit

• To identify clinical subgroups of PCOS and associated comorbidities.

  one visit

• To understand the genetics underlying these conditions and explore the relevant downstream molecular pathways

  one visit

• To identify novel drug targets, develop models of disease progression and prediction.

  one visit

Study Arms (10)

PCOS

No intervention.

Other: No intervention

PCOS surgery

No intervention

Other: No intervention

Surgery control

No intervention

Other: No intervention

IVF PCOS

No intervention

Other: No intervention

IVF control

No intervention

Other: No intervention

Investigations, fertility PCOS

No intervention

Other: No intervention

Investigations, fertility control

No intervention

Other: No intervention

Pregnancy - gestational diabetes mellitus

No intervention

Other: No intervention

Pregnancy - Intrahepatic cholestasis of pregnancy

No intervention

Other: No intervention

Pregnancy - control

No intervention

Other: No intervention

Interventions

No intervention OTHER

There is no intervention in this study

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

Eligibility Criteria

• Age: 16 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with and without OCOS and known associated phenotypes

You may qualify if:

• ● 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 :

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oxford: lead
• Bayer: collaborator
• Li Ka Shing Foundation: collaborator

Study Sites (1)

Nuffield Department Women's and Reproductive Health

Oxford, Oxfordshire, OX3 9DU, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, fat, ovarian tissue, endometrium biopsy, cumulus/granulosa cells, follicular fluid.

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Central Study Contacts

RepOx Research Midwife

CONTACT

++441865 572258; osprea@wrh.ox.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 4, 2022
• Study Start: October 21, 2021
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: January 4, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)