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

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ClinicalTrials.gov Identifier: NCT03652987
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : April 12, 2019
Sponsor:
Collaborator:
SPD Development Company Limited
Information provided by (Responsible Party):
St George's, University of London

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.

Condition or disease
Polycystic Ovary Syndrome Insulin Resistance Vitamin D Deficiency Obesity

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.
Actual Study Start Date : September 5, 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : September 2023

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose. [ Time Frame: 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


Secondary Outcome Measures :
  1. Measurement of BMI [ Time Frame: 6 months ]
    BMI between different patient types


Biospecimen Retention:   Samples Without DNA
Urine and serum sample


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female reproductive organs need to be present i.e. ovaries and uterus
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women with polycystic ovary syndrome (PCOS)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652987


Contacts
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Contact: Suman Rice, PhD 02087251155 srice@sgul.ac.uk
Contact: Nadia Azzouzi 020 8266 6488 nazzouzi@sgul.ac.uk

Locations
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United Kingdom
St George's Hospital Trust Recruiting
London, United Kingdom, SW17 0RE
Contact: Gul Bano, MD       gul.bano@stgeorges.nhs.uk   
Contact: Suman Rice, PhD    02087251155    srice@sgul.ac.uk   
Sponsors and Collaborators
St George's, University of London
SPD Development Company Limited

Additional Information:

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Responsible Party: St George's, University of London
ClinicalTrials.gov Identifier: NCT03652987    
Other Study ID Numbers: 18.0049
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St George's, University of London:
PCOS
Hyperandrogenemia
Rotterdam Criteria
Insulin sensitivity
BMI
Antral follicle count
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Insulin Resistance
Vitamin D Deficiency
Syndrome
Menstruation Disturbances
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Avitaminosis
Deficiency Diseases
Malnutrition
Nutrition Disorders