Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women

NCT ID: NCT03518918

Last Updated: 2018-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-01

Study Completion Date

2021-12-01

Brief Summary

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The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.

Detailed Description

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Premature ovarian insufficiency (POI) is a clinical syndrome defined by loss of ovarian activity before the age of 40 years. The POI guideline development group of ESHRE recommends the following diagnostic criteria: oligo/amenorrhea for at least 4 months and an elevated follicle stimulating hormone (FSH) level \>25 mIU/mL on two occasion \>4 weeks apart. But there still no diagnosis standard of POI in Chinese.The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.

Conditions

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Primary Ovarian Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Infertility
* The length of menstrual cycle longer than 35 days or shorter than/amenorrhea
* Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤7, on at least two occasion \>4 weeks apart

Exclusion Criteria

* Polycystic Ovarian Syndrome
* other causes of amenorrhea
Minimum Eligible Age

12 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Queen Mary Hospital, Hong Kong

OTHER

Sponsor Role collaborator

Southern Medical University, China

OTHER

Sponsor Role collaborator

The Third Affiliated Hospital of Southern Medical University

OTHER_GOV

Sponsor Role collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role collaborator

Shen-Zhen City Maternity and Child Healthcare Hospital

OTHER

Sponsor Role collaborator

Guangdong Provincial Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role collaborator

Nanfang Hospital, Southern Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shi-ling Chen, M.D, Ph.D

Role: STUDY_CHAIR

Nanfang Hospital, Southern Medical University

Locations

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Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shi-ling Chen, M.D, Ph.D

Role: CONTACT

+86-020-62787604

Facility Contacts

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Shi-Ling Chen, M.D., Ph.D.

Role: primary

+86-20-62787604

Other Identifiers

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NFEC-2016-141

Identifier Type: -

Identifier Source: org_study_id

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