Polycystic Ovary SyndromeNCT01600833
The Association of Ferrtin and Homocysteine Etc. With RI and MS in Polycystic Ovary Syndrome (PCOS)
An observational study of Polycystic Ovary Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 539 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2012to Mar 2013
- 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: Female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
Who may be able to join
- female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
Who cannot join
- women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)
- women who had menopause
- women with inadequate clinical/biochemical records
- women who had had ovarian cysts or ovarian tumors
- women who took hormone, medicine for Diabetes and/or cardiovascular disease.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan, 110
About this study
Official title: To Association of Serum Ferrtin and Homocysteine Levels With Insulin Resistence and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Ferritin, Homocysteine, Insulin Resistance, Metabolic Syndrome
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Obese women | BMI>25 | |
| Non obese women | BMI<25 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum ferritin levels in obese and non-obese women.
The pathogenesis of increased iron stores correlated with insulin resistance and metabolic syndrome among obese and non-obese premenopausal women was different. The hypertriglyceridemia in women with PCOS might be associated with iron metabolism.
Measured: the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2012 (estimated)
- Study startMar 2012
- Primary completionMar 2013
- Study completionMar 2013
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
- Retrospective
- Enrolment
- 539 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-I Hsu, Taipei Medical University WanFang Hospital
- Investigators
- Ming I Hsu, MD, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01600833
- Sponsor's protocol ID
- WFH-TMU-PCOS-201111006
- Status last verified
- Nov 2013
- First submitted
- 15 May 2012
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Association of Serum Ferrtin and Homocysteine Levels With Insulin Resistence and Metabolic Syndrome in Women With Polycystic Ovary Syndrome
- ClinicalTrials.gov ID
- NCT01600833
- Acronym / sponsor ID
- WFH-TMU-PCOS-201111006
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- PCOS, Ferritin, Homocysteine, Insulin Resistance, Metabolic Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 539 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 17 May 2012 (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.
The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Obese women | – | –BMI>25 |
| Non obese women | – | –BMI<25 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
Key inclusion criteria (1 listed)
- female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.
Key exclusion criteria (5 listed)
- women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)
- women who had menopause
- women with inadequate clinical/biochemical records
- women who had had ovarian cysts or ovarian tumors
- women who took hormone, medicine for Diabetes and/or cardiovascular disease.
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
Serum ferritin levels in obese and non-obese women.
Time frame: the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.
The pathogenesis of increased iron stores correlated with insulin resistance and metabolic syndrome among obese and non-obese premenopausal women was different. The hypertriglyceridemia in women with PCOS might be associated with iron metabolism.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2013.
Related trials for Polycystic Ovary Syndrome
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
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.
Ming I Hsu, MD principal investigator
Taipei Medical University WanFang Hospital
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 Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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: finished, as of the sponsor's last update on 7 Nov 2013. 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 Taiwan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Serum ferritin levels in obese and non-obese women. (time frame: the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.). 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 7 Nov 2013.