PCOS (Polycystic Ovarian Syndrome) Patients

Health Related Clinical Trial

Official title:

Prospective Cohort Study for PCOS Patients in Clinical Reproductive Medicine Management System/Electronic Medical Record Cohort Database (CCRM/EMRCD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03991507
• Other study ID #: RMCZZU-PCOS cohort study
• Status: Recruiting
• Start date: January 1, 2010
• Est. completion date: December 31, 2050

Study information

• Verified date: June 2019
• Source: The First Affiliated Hospital of Zhengzhou University
• Contact: Lanlan Fang, M.D.
• Phone: 13673355291
• Email: fanglly[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2050
• Est. primary completion date: December 31, 2050
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• PCOS patients diagnosed with The Rotterdam diagnostic criteria.

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Health Related
• Polycystic Ovary Syndrome

Locations

Country	Name	City	State
China	Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Zhengzhou University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Level of serum FSH (Follicle stimulating hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Primary	Level of serum LH (Luteinizing hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Primary	Level of T (Testosterone)	ng/ml	From date of inclusion, assessed by each 12 month, up to 40 years
Secondary	Body Weight	Recorded in Kilograms	From date of inclusion, assessed by each 12 month, up to 40 years
Secondary	Height	Recorded in centimeters	From date of inclusion, assessed by each 12 month, up to 40 years