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

NCT03652987 | Suspended

• 1 other identifier: 18.0049
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

PCOS; Hyperandrogenemia; Rotterdam Criteria; Insulin sensitivity; BMI; Antral follicle count

Outcome Measures

Primary Outcomes (1)

• Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose.

  Statistically significant differences in: levels of hormone/factors produced as measured in blood and urine samples sent to pathology lab; hormonal \& metabolic responses/parameters after dietary/pharmaceutical intervention

  6 months

Secondary Outcomes (1)

• Measurement of BMI

  6 months

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Female reproductive organs need to be present i.e. ovaries and uterus
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Women with polycystic ovary syndrome (PCOS)

You may qualify if:

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

Sponsors & Collaborators

• St George's, University of London: lead
• SPD Development Company Limited: collaborator

Study Sites (1)

St George's Hospital Trust

London, SW17 0RE, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Urine and serum sample

MeSH Terms

Conditions

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

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; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Overweight; Overnutrition; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Suman Rice, PhD

  St George's, University of London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2018
• First Posted: August 31, 2018
• Study Start: September 5, 2018
• Primary Completion: December 1, 2022
• Study Completion: September 1, 2023
• Last Updated: May 25, 2021

Record last verified: 2020-06

Locations

GB (1)