Clinical trial NCT03518918: Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women
Official title: Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Ovarian Insufficiency
Keywords: Premature ovarian insufficiency
Diagnosis standard
Risk factors
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
Collaborators: name: Queen Mary Hospital, Hong Kong
name: Southern Medical University, China
name: The Third Affiliated Hospital of Southern Medical University
name: Shenzhen Hospital of Southern Medical University
name: Shen-Zhen City Maternity and Child Healthcare Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2018-05-08
Enrollment: 50000
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 39
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Female under the condition of diminished ovarian reserve were enrolled in the study. The condition of diminished ovarian reserve may be the early stage of premature ovarian insufficiency.

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change of serum FSH levels
timeFrame: through study completion, an average of 3 months, assessed up to 48 months
measure: Menstruation situation
timeFrame: through study completion, an average of 3 months, assessed up to 48 months
Secondary outcomes:
measure: Change of Antral follicle count
timeFrame: through study completion, an average of 3 months, assessed up to 48 months
measure: Change of anti-mullerian hormone levels
timeFrame: through study completion, an average of 3 months, assessed up to 48 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Shi-ling Chen, M.D, Ph.D
role: STUDY_CHAIR
References: