Establishing of an Early Warming System of Premature Ovarian Insufficiency

Nanfang Hospital, Southern Medical University

Status: Unknown

Conditions: Primary Ovarian Insufficiency

Study type: Observational

Funder types: Other

Identifiers

NCT03518944

NFEC-2017-197

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: Female

Ages: 12 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

500 participants in 1 patient group

occult premature ovarian insufficiency

Description:

Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart