Polycystic Ovary SyndromeNCT02676518
AMH, Glucose Intolerance and Metabolic Syndrome in PCOS
An observational study of Polycystic Ovary Syndrome, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS) Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- serum
- Type of treatment
- Pill or oral medicine
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Apr 2015to May 2016
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Thai women with PCOS diagnosed by Rotterdam criteria 2003 who visit at Gynecological Department, King Chulalongkorn Memorial Hospital, Bangkok,Thailand
Who may be able to join
- PCOS diagnosed by Rotterdam criteria 2003
Who cannot join
- Pregnancy
- Previous any hormonal uses in the last 3 months
- Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
- Previous chemotherapy, ovarian surgery, pelvic irradiation
- Menopause
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
Bangkok, Bangkok, 10330
Wasamon Tunsuparp, MD, wasamontun@gmail.com
Porntip Sirayapiwat, MD, MSc, p_siraya@hotmail.com
About this study
Official title: Anti-Müllerian Hormone and Its Association With Glucose Intolerance and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)
Read the detailed description
- To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).
- Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).
- Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.
- Elevated waist circumference (> 80 cm in Asian women)
- Elevated triglycerides (> 150 mg/dL)
- Reduced HDL-cholesterol (< 50 mg/dL)
- Elevated blood pressure )systolic > 130 and/or diastolic > 85 mmHg)
- Elevated fasting glucose ( > 100 mg/dL)
- Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- serum
- Keywords
- polycystic ovary syndrome, Serum anti-Mullerian hormone, glucose intolerance, metabolic syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Glucose Intolerance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
serumOther
Serum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles
| Study group | Role | What they receive |
|---|---|---|
| polycystic ovary syndrome women | PCOS women diagnosed by Rotterdam criteria visiting the Gynecologic Unit at King Chulalongkorn Memorial Hospital and meet the inclusion criteria and no exclusion criteria of the study Receives: Other: serum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome
Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome
Measured: 6 months
Secondary outcomes (2)
Percentage of glucose intolerance in PCOS women
Percentage of glucose intolerance detected by 75 g OGTT in PCOS women
Measured: 6 months
Percentage of metabolic syndrome in PCOS women
Percentage of metabolic syndrome defined by the Harmonized criteria in PCOS women
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 posted8 Feb 2016 (estimated)
- Study startApr 2015
- Primary completionMay 2016 (estimated)
- Study completionMay 2016 (estimated)
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.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Porntip Sirayapiwat, Chulalongkorn University
- Investigators
- Dhirapong Charoenvidya, MD, Study chair, Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02676518
- Sponsor's protocol ID
- 057/2015
- Status last verified
- Feb 2016
- First submitted
- 19 Aug 2015
- Last updated
- 8 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anti-Müllerian Hormone and Its Association With Glucose Intolerance and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT02676518
- Acronym / sponsor ID
- 057/2015
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- polycystic ovary syndrome, Serum anti-Mullerian hormone, glucose intolerance, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- May 2016 (estimated)
- Study completion
- May 2016 (estimated)
- First posted
- 8 Feb 2016 (estimated)
- 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.
Association between serum anti-Mullerian hormone (AMH) level and prevalence of glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS)
Detailed description
- To study the association between serum anti-Mullerian hormone (AMH) level and glucose intolerance and metabolic syndrome in women with polycystic ovary syndrome (PCOS).
- Glucose intolerance is detected by 2-hours 75 gram oral glucose tolerance test (OGTT).
- Metabolic syndrome is diagnosed by using the Harmonized criteria; the presence of any 3 of 5 following risk factors constitutes a diagnosis of metabolic syndrome.
- Elevated waist circumference (> 80 cm in Asian women)
- Elevated triglycerides (> 150 mg/dL)
- Reduced HDL-cholesterol (< 50 mg/dL)
- Elevated blood pressure )systolic > 130 and/or diastolic > 85 mmHg)
- Elevated fasting glucose ( > 100 mg/dL)
- Percentage of glucose intolerance and metabolic syndrome in PCOS women as well was any differences in parameters between PCOS patients with and without glucose intolerance and metabolic syndrome will be analysed.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| polycystic ovary syndrome women | – | Other: serumPCOS women diagnosed by Rotterdam criteria visiting the Gynecologic Unit at King Chulalongkorn Memorial Hospital and meet the inclusion criteria and no exclusion criteria of the study |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Thai women with PCOS diagnosed by Rotterdam criteria 2003 who visit at Gynecological Department, King Chulalongkorn Memorial Hospital, Bangkok,Thailand
Key inclusion criteria (1 listed)
- PCOS diagnosed by Rotterdam criteria 2003
Key exclusion criteria (5 listed)
- Pregnancy
- Previous any hormonal uses in the last 3 months
- Previous hypoglycemic drugs or insulin-sensitising agents use in the last 3 months
- Previous chemotherapy, ovarian surgery, pelvic irradiation
- Menopause
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| serumSerum for serum anti-Mullerian hormone, 2-hour 75 gram oral glucose tolerance test and lipid profiles | Other | polycystic ovary syndrome women |
Primary outcome
Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome
Time frame: 6 months
Any differences between mean of serum AMH levels in PCOS with and without glucose intolerance and metabolic syndrome
2 secondary outcomes
Percentage of glucose intolerance in PCOS women
Time frame: 6 months
Percentage of metabolic syndrome in PCOS women
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 8 Feb 2016.
- Individual participant dataSharing planned: Yes
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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.
Dhirapong Charoenvidya, MD study chair
Department of Obstetrics and Gynecology, Faculty of Medicine, Chulalongkorn University
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, run by Chulalongkorn University at 1 site in Thailand.
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 5 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: status not confirmed, as of the sponsor's last update on 8 Feb 2016. 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 Thailand. 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?
Contact Wasamon Tunsuparp, MD (66850658502, wasamontun@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences between serum AMH level between PCOS women with and without glucose intolerance and metabolic syndrome (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 8 Feb 2016.