NCT03991507

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
299mo left

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Jan 2010Dec 2050

Study Start

First participant enrolled

January 1, 2010

Completed
9.5 years until next milestone

First Submitted

Initial submission to the registry

June 13, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 19, 2019

Completed
31.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2050

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2050

Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

41 years

First QC Date

June 13, 2019

Last Update Submit

June 18, 2019

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Body Weight

    From date of inclusion, assessed by each 12 month, up to 40 years

  • Height

    From date of inclusion, assessed by each 12 month, up to 40 years

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

PCOS patients diagnosed with The Rotterdam diagnostic criteria.

You may qualify if:

  • PCOS patients diagnosed with The Rotterdam diagnostic criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reproductive Medical Center, First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, 450052, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample

Central Study Contacts

Lanlan Fang, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Reproductive Medical Center

Study Record Dates

First Submitted

June 13, 2019

First Posted

June 19, 2019

Study Start

January 1, 2010

Primary Completion (Estimated)

December 31, 2050

Study Completion (Estimated)

December 31, 2050

Last Updated

June 19, 2019

Record last verified: 2019-06

Locations