Establishing of an Early Warming System of Premature Ovarian Insufficiency
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Ovarian Insufficiency
- Sponsor
- Nanfang Hospital, Southern Medical University
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- the change of menstruation situation
- Last Updated
- 7 years ago
Overview
Brief Summary
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. Some clinicians and researchers proposed that POI was a progressive disease and there were three stages of POI: occult POI, biochemical POI, overt POI. However, there is lack of reliable indicators to assess the different stages of POI. The present study is to explore the change of menstruation condition, basal follicle-stimulating hormone, anti-müllerian hormone and antral follicle count during the development of POI, and whether those marks can assess the different stages of POI.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart
Exclusion Criteria
- •Polycystic Ovarian Syndrome
- •other causes of amenorrhea
Outcomes
Primary Outcomes
the change of menstruation situation
Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Menstrual cycle
the change of serum follicle-stimulating hormone levels
Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
the serum FSH levels between day 2 to day 5 of menstrual cycle
the change of serum anti-mullerian hormone levels
Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
the serum anti-mullerian hormone levels between day 2 to day 5 of menstrual cycle
the change of antral follicle count
Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Antral follicle count between day 2 to day 5 of menstrual cycle