Health RelatedNCT03991507
PCOS (Polycystic Ovarian Syndrome) Patients
An observational study of Health Related, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
Trial summary
The Prospective Cohort Study for PCOS Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Health Related
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2010to 31 Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Study population: PCOS patients diagnosed with The Rotterdam diagnostic criteria.
Who may be able to join
- PCOS patients diagnosed with The Rotterdam diagnostic criteria.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Zhiqin Bu, M.D., 15981978863, rmczzu@126.com
About this study
Official title: Prospective Cohort Study for PCOS Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
The Prospective Cohort Study for PCOS Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.
Read the detailed description
Polycystic ovary syndrome (PCOS) affects 8-13% of women. It is a multifaceted condition characterized by chronic anovulation and excess ovarian activity.
Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit PCOS participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for PCOS prognosis.
- Conditions
- Health Related
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of serum FSH (Follicle stimulating hormone)
mIU/mL
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Level of serum LH (Luteinizing hormone)
mIU/mL
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Level of T (Testosterone)
ng/ml
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Secondary outcomes (2)
Body Weight
Recorded in Kilograms
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Height
Recorded in centimeters
Measured: From date of inclusion, assessed by each 12 month, up to 40 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2019
- Study start1 Jan 2010
- Primary completion31 Dec 2050 (estimated)
- Study completion31 Dec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Health RelatedStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Zhengzhou 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yingpu Sun, The First Affiliated Hospital of Zhengzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03991507
- Sponsor's protocol ID
- RMCZZU-PCOS cohort study
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 19 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study for PCOS Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
- ClinicalTrials.gov ID
- NCT03991507
- Acronym / sponsor ID
- RMCZZU-PCOS cohort study
- Conditions
- Health Related
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Zhengzhou UniversityUniversity, hospital or other
- Study start
- 1 Jan 2010 (actual)
- Primary completion
- 31 Dec 2050 (estimated)
- Study completion
- 31 Dec 2050 (estimated)
- First posted
- 19 Jun 2019 (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.
The Prospective Cohort Study for PCOS Patients was set up to investigate the short- and long-term health consequences in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, China.
Detailed description
Polycystic ovary syndrome (PCOS) affects 8-13% of women. It is a multifaceted condition characterized by chronic anovulation and excess ovarian activity.
Since last decade, Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD) has been used in Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University, and Henan Province Key Laboratory for Reproduction and Genetics. Information of patients (POI, PCOS, Endometriosis, azoospermia, ect) were recorded comprehensively. The current project plans to recruit PCOS participants in our center. Biological samples, questionnaires and short/long term health data will be collected. The study is aimed to provide evidence for PCOS prognosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- PCOS patients diagnosed with The Rotterdam diagnostic criteria.
Key inclusion criteria (1 listed)
- PCOS patients diagnosed with The Rotterdam diagnostic criteria.
Key exclusion criteria (1 listed)
- -
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
Level of serum FSH (Follicle stimulating hormone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
mIU/mL
Level of serum LH (Luteinizing hormone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
mIU/mL
Level of T (Testosterone)
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
ng/ml
2 secondary outcomes
Body Weight
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
Height
Time frame: From date of inclusion, assessed by each 12 month, up to 40 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jun 2019.
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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.
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 Health Related, run by The First Affiliated Hospital of Zhengzhou University at 1 site in China.
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: looking for participants now, as of the sponsor's last update on 19 Jun 2019. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lanlan Fang, M.D. (13673355291, fanglly@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of serum FSH (Follicle stimulating hormone) (time frame: From date of inclusion, assessed by each 12 month, up to 40 years). The study lists 3 primary outcomes in all. 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 19 Jun 2019.