- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03991507
PCOS (Polycystic Ovarian Syndrome) Patients
Prospective Cohort Study for PCOS Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Lanlan Fang, M.D.
- Phone Number: 13673355291
- Email: fanglly@163.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450052
- Recruiting
- Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University
-
Contact:
- Zhiqin Bu, M.D.
- Phone Number: 15981978863
- Email: rmczzu@126.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- PCOS patients diagnosed with The Rotterdam diagnostic criteria.
Exclusion Criteria:
-
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Level of serum FSH (Follicle stimulating hormone)
Time Frame: From date of inclusion, assessed by each 12 month, up to 40 years
|
mIU/mL
|
From date of inclusion, assessed by each 12 month, up to 40 years
|
Level of serum LH (Luteinizing hormone)
Time Frame: From date of inclusion, assessed by each 12 month, up to 40 years
|
mIU/mL
|
From date of inclusion, assessed by each 12 month, up to 40 years
|
Level of T (Testosterone)
Time Frame: From date of inclusion, assessed by each 12 month, up to 40 years
|
ng/ml
|
From date of inclusion, assessed by each 12 month, up to 40 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Body Weight
Time Frame: From date of inclusion, assessed by each 12 month, up to 40 years
|
Recorded in Kilograms
|
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
|
Recorded in centimeters
|
From date of inclusion, assessed by each 12 month, up to 40 years
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RMCZZU-PCOS cohort study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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