Polycystic Ovary SyndromeEMDPCOSNCT03652987
Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by St George's, University of London at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Insulin Resistance, Vitamin D Deficiency
- How many people
- 300 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Sep 2018to Sep 2023
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Women with polycystic ovary syndrome (PCOS)
Who may be able to join
- Premenopausal women with PCOS (Rotterdam criteria) attending the endocrine clinic, aged between 18-45 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.
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.
Read the 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.
- Keywords
- PCOS, Hyperandrogenemia, Rotterdam Criteria, Insulin sensitivity, BMI, Antral follicle count
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Vitamin D Deficiency, Obesity
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Secondary outcomes (1)
Measurement of BMI
BMI between different patient types
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2018
- Study start5 Sep 2018
- Primary completionDec 2022 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: Covid19-related restrictions
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- St George's, University of London
- Sponsor type
- University, hospital or other
- Collaborators
- SPD Development Company Limited
- Responsible party
- Sponsor
- Investigators
- Suman Rice, PhD, Principal investigator, St George's, University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03652987
- Sponsor's protocol ID
- 18.0049
- Acronym
- EMDPCOS
- Status last verified
- Jun 2020
- First submitted
- 28 Aug 2018
- Last updated
- 25 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Endocrine and Menstrual Disturbances in Women With Polycystic Ovary Syndrome (PCOS): Impact of Weight, Metabolic Status, Age and Ethnicity.
- ClinicalTrials.gov ID
- NCT03652987
- Acronym / sponsor ID
- EMDPCOS / 18.0049
- Keywords
- PCOS, Hyperandrogenemia, Rotterdam Criteria, Insulin sensitivity, BMI, Antral follicle count
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Covid19-related restrictions
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- St George's, University of LondonUniversity, hospital or other
- Collaborators
- SPD Development Company Limited
- Study start
- 5 Sep 2018 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 31 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Women with polycystic ovary syndrome (PCOS)
Key inclusion criteria (1 listed)
- Premenopausal women with PCOS (Rotterdam criteria) attending the endocrine clinic, aged between 18-45 years
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
Measurement of BMI
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suman Rice, PhD principal investigator
St George's, University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome and Insulin Resistance, run by St George's, University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assay measurements of hormones in blood and urine samples i.e. testosterone, SHBG, FSH, LH, VD, AMH, fasting insulin & glucose. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2021.