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

Study Overview
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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.

Official Title
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Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study

Conditions
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Primary Ovarian Insufficiency

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of serum FSH levels | the serum FSH levels between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first. | through study completion, an average of 3 months, assessed up to 48 months | 
| Menstruation situation | the length of the menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first. | through study completion, an average of 3 months, assessed up to 48 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Antral follicle count | the Antral follicle count between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first. | through study completion, an average of 3 months, assessed up to 48 months | 
| Change of anti-mullerian hormone levels | the anti-mullerian hormone between day 2 to day 5 of menstrual cycle from date of recruit until the date of study completion or date of twice FSH level >25mIU/mL, whichever came first. | through study completion, an average of 3 months, assessed up to 48 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Premature ovarian insufficiency, Diagnosis standard, Risk factors