PCOS (Polycystic Ovarian Syndrome) Patients | NCT03991507

Studies
PCOS (Polycystic Ovarian Syndrome) Patients

NCT03991507

Sponsor

The First Affiliated Hospital of Zhengzhou University

Status

Recruiting

Last Update Posted

Jun 19, 2019Actual

Enrollment

10,000Estimated

Phase

Not provided

Conditions

Health Related

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2019

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2010Actual

Primary Completion Date

Dec 31, 2050Estimated

Completion Date

Dec 31, 2050Estimated

First Submitted Date

Jun 13, 2019

First Submission Date that Met QC Criteria

Jun 18, 2019

First Posted Date

Jun 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2019

Last Update Posted Date

Jun 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Yingpu Sun, Director of Reproductive Medical Center, The First Affiliated Hospital of Zhengzhou UniversityPrincipal Investigator

Lead Sponsor

The First Affiliated Hospital of Zhengzhou UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

10,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Level of serum FSH (Follicle stimulating hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Level of serum LH (Luteinizing hormone)	mIU/mL	From date of inclusion, assessed by each 12 month, up to 40 years
Level of T (Testosterone)	ng/ml	From date of inclusion, assessed by each 12 month, up to 40 years

Secondary Outcomes

Measure	Description	Time Frame
Body Weight	Recorded in Kilograms	From date of inclusion, assessed by each 12 month, up to 40 years
Height	Recorded in centimeters

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

PCOS patients diagnosed with The Rotterdam diagnostic criteria.

Exclusion Criteria:

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

PCOS patients diagnosed with The Rotterdam diagnostic criteria.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Lanlan Fang, M.D.	Contact	13673355291		fanglly@163.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University	Recruiting	Zhengzhou	Henan	450052	China