Primary Ovarian Insufficiency
Conditions
Keywords
Premature ovarian insufficiency, Diagnosis standard, Risk factors
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.
Interventions
None listed
Sponsors
Queen Mary Hospital, Hong Kong
Southern Medical University, China
The Third Affiliated Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University
Shen-Zhen City Maternity and Child Healthcare Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
12 Years to 39 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of serum FSH levels | through study completion, an average of 3 months, assessed up to 48 months | 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. |
| Menstruation situation | through study completion, an average of 3 months, assessed up to 48 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Antral follicle count | through study completion, an average of 3 months, assessed up to 48 months | 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. |
| Change of anti-mullerian hormone levels | through study completion, an average of 3 months, assessed up to 48 months | 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. |
Countries
China
Contacts
Primary ContactShi-ling Chen, M.D, Ph.D
Outcome results
None listed