An observational study in Polycystic Ovary Syndrome, Insulin Resistance and Vitamin D Deficiency, sponsored by St George's, University of London. Suspended at 1 site in United Kingdom. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2021-05-25.
Sponsored by St George's, University of London · Observational
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.
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:
Part 1 of the research protocol will include obtaining the following:
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 300 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →St George's, University of London is the lead sponsor of 105 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women with polycystic ovary syndrome (PCOS)
Exclusion Criteria:
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
Time frame: 6 months
Measurement of BMI
BMI between different patient types
Time frame: 6 months
This study is suspended, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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St George's, University of London