Polycystic Ovary SyndromeNCT01350895
Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group
An observational study of Polycystic Ovary Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
Trial summary
To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups. Read more about this study
- Who is it for?
- Ages 18 to 46 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- How many people
- 781 participants
- Where
- 1 siteTaiwan
- Study dates
- Feb 2011to Apr 2012
- 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 46 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Reproductive age women
Who may be able to join
- Reproductive age women with sufficient data
Who cannot join
- Disorders of uterus (e.g. Asherman's Syndrome, Mullerian agenesis) and chromosomal anomalies (e.g. Turner syndrome)
- women who had had menarche at less than 3 years of age, Day 3 FSH > 15, or who were older than 46
- women with inadequate clinical/biochemical records
- and women who had had ovarian cysts or ovarian tumors in ultrasonography examination
- pregnancy women
Trial locations and contacts
1 site in 1 country.
About this study
To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups.
Read the detailed description
Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. We are plan using retrospective analysis to evaluate the clinical and biochemical presentation of PCOS in different aged groups.
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovarian syndrome (PCOS)
- Medical subject headings
- Polycystic Ovary 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 |
|---|---|---|
| Experimental Group | Not described | |
| Control Group | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2011 (estimated)
- Study startFeb 2011
- Primary completionApr 2012
- Study completionApr 2012
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
- Time perspective
- Retrospective
- Enrolment
- 781 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, Principal investigator, Taipei Medical University WanFang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01350895
- Sponsor's protocol ID
- WFH-PCOS-100002
- Status last verified
- Nov 2013
- First submitted
- 9 May 2011
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Biochemical Presentation of Polycystic Ovary Syndrome in Different Age Group
- ClinicalTrials.gov ID
- NCT01350895
- Acronym / sponsor ID
- WFH-PCOS-100002
- Conditions
- Polycystic Ovary Syndrome
- Keywords
- Polycystic ovarian syndrome (PCOS)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 781 participants (actual)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Feb 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 10 May 2011 (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.
To study the clinical and biochemical characteristics women with polycystic ovary syndrome (PCOS) in different aged groups.
Detailed description
Polycystic ovarian syndrome (PCOS) is the most frequent endocrine disorder of reproductive age women, affecting an estimated 9-18% of all women in this age group. To diagnose of PCOS in early life is especially important because it is now thought to increase metabolic and cardiovascular risks. Investigating PCOS is crucial as it is now considered to increase metabolic and cardiovascular risk, thereby impacting the health of women to a much greater extent than previously thought. We are plan using retrospective analysis to evaluate the clinical and biochemical presentation of PCOS in different aged groups.
Study design
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | – | – |
| Control Group | – | – |
Who may qualify
- Ages
- 18 to 46 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Reproductive age women
Key inclusion criteria (1 listed)
- Reproductive age women with sufficient data
Key exclusion criteria (5 listed)
- Disorders of uterus (e.g. Asherman's Syndrome, Mullerian agenesis) and chromosomal anomalies (e.g. Turner syndrome)
- women who had had menarche at less than 3 years of age, Day 3 FSH > 15, or who were older than 46
- women with inadequate clinical/biochemical records
- and women who had had ovarian cysts or ovarian tumors in ultrasonography examination
- pregnancy women
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
Not reported in the source record.
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 6 Nov 2013.
Related trials for Polycystic Ovary Syndrome
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
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 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 6 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.
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 6 Nov 2013.