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临床试验/NCT03652987
NCT03652987暂停不适用

Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.

St George's, University of London1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2018年9月5日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
300
试验地点
1
主要终点
Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose.

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • There is a clear exclusion criteria under the Rotterdam criteria; age <18 years or >45 years; oral contraceptive use within 3 months prior to recruitment, diabetes mellitus & pregnancy

结局指标

主要结局

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

时间窗: 6 months

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

次要结局

  • Measurement of BMI(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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