Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)

NCT ID: NCT03652987

Last Updated: 2021-05-25

Basic Information

• Recruitment Status: SUSPENDED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-05
• Study Completion Date: 2023-09-30

Brief Summary

Polycystic ovary syndrome (PCOS) is a common endocrine disorder in reproductive age women, which causes disordered follicle growth and ovulation resulting in infertility. In addition women with PCOS have hyperandrogenemia and a dysregulated hormonal profile, resulting in altered feedback on the hypothalamic-pituitary-gonadal (HPG) axis. Obesity, insulin resistance, vitamin D (VD) deficiency and ageing worsen the symptoms. The gonadotrophins - follicle stimulating hormone (FSH) & luteinising hormone (LH), along with the pregnancy hormone human chorionic gonadotrophin (hCG) have structural similarities. The altered levels of FSH and LH in women with PCOS cause production of hCG from the brain leading to false positive pregnancy tests. Part one of this project will involve the investigation of this over-production of hCG in urine and serum of women with PCOS to develop suitable ovulation and pregnancy test kits, in collaboration with Swiss Precision Diagnostics (SPD). In Part two of the project, we would like to see if intervention with VD supplementation and/or using myo-inositol supplement compared with metformin (insulin sensitiser), improves prediabetes, distribution of fat/water content, weight loss and menstrual cyclicity in women with PCOS. We aim to correlate these interventions with particular serum & urine markers to develop better diagnostic tools.

Detailed Description

Women are referred by the general practioner (GP)/primary care with a suspected diagnosis of PCOS to the Endocrine Clinic at St George's Hospital.

They have an initial routine clinical assessment involving history, BP, weight & assessment of PCOS using the Rotterdam criteria.

The routine clinical investigations involve the following:

• one fasting blood sample to measure various hormones; fasting glucose:insulin ratio; pelvic ultrasound scan to determine ovarian morphology, follicular count and endometrial thickness

Part 1 of the research protocol will include obtaining the following:

• One urine & serum sample to be taken at the same time as their routine clinical blood samples.
• These samples will be anonymised before despatch to SPD. Part 2 of the study will involve treating patients with Vitamin D (if they are deficient) and/or myo-inositol supplement or metformin depending on their clinical need. The outcomes measured will be as above (blood sample to measure hormones) and an assessment of body fat distribution.

Conditions

Polycystic Ovary Syndrome; Insulin Resistance; Vitamin D Deficiency; Obesity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Premenopausal women with PCOS (Rotterdam criteria) attending the endocrine clinic, aged between 18-45 years

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

SPD Development Company Limited

INDUSTRY

Sponsor Role: collaborator

St George's, University of London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Suman Rice, PhD

Role: PRINCIPAL_INVESTIGATOR

St George's, University of London

Locations

St George's Hospital Trust

London, , United Kingdom

Countries

United Kingdom

Other Identifiers

18.0049

Identifier Type: -

Identifier Source: org_study_id