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

N

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Primary Ovarian Insufficiency

Study type

Observational

Funder types

Other

Identifiers

NCT03518918
NFEC-2016-141

Details and patient eligibility

About

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

Full description

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.

Enrollment

50,000 estimated patients

Sex

Female

Ages

12 to 39 years old

Volunteers

No Healthy Volunteers

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

Trial contacts and locations

1

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Central trial contact

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

Data sourced from clinicaltrials.gov

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