Clinical trial NCT03652987: Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
Official title: Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.
Study type: OBSERVATIONAL
Overall status: SUSPENDED
Conditions: Polycystic Ovary Syndrome
Insulin Resistance
Vitamin D Deficiency
Obesity
Keywords: PCOS
Hyperandrogenemia
Rotterdam Criteria
Insulin sensitivity
BMI
Antral follicle count
Lead sponsor: St George's, University of London
Sponsor class: OTHER
Collaborators: name: SPD Development Company Limited
First posted: 2018-08-31
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with polycystic ovary syndrome (PCOS)

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose.
timeFrame: 6 months
Secondary outcomes:
measure: Measurement of BMI
timeFrame: 6 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's Hospital Trust
Study officials:
affiliation: St George's, University of London
name: Suman Rice, PhD
role: PRINCIPAL_INVESTIGATOR
References: