Clinical trial NCT03518944: Establishing of an Early Warming System of Premature Ovarian Insufficiency
Official title: Establishing of an Early Warming System of Premature Ovarian Insufficiency
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Ovarian Insufficiency
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 500
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients of occult premature ovarian insufficiency

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.


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

Primary outcomes:
measure: the change of serum follicle-stimulating hormone levels
timeFrame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
measure: the change of menstruation situation
timeFrame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
measure: the change of serum anti-mullerian hormone levels
timeFrame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
measure: the change of antral follicle count
timeFrame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Secondary outcomes:
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: Shiling Chen, M.D./Ph.D.
role: STUDY_CHAIR
References:
citation: European Society for Human Reproduction and Embryology (ESHRE) Guideline Group on POI; Webber L, Davies M, Anderson R, Bartlett J, Braat D, Cartwright B, Cifkova R, de Muinck Keizer-Schrama S, Hogervorst E, Janse F, Liao L, Vlaisavljevic V, Zillikens C, Vermeulen N. ESHRE Guideline: management of women with premature ovarian insufficiency. Hum Reprod. 2016 May;31(5):926-37. doi: 10.1093/humrep/dew027. Epub 2016 Mar 22.
citation: Welt CK. Primary ovarian insufficiency: a more accurate term for premature ovarian failure. Clin Endocrinol (Oxf). 2008 Apr;68(4):499-509. doi: 10.1111/j.1365-2265.2007.03073.x. Epub 2007 Oct 29.