Establishing of an Early Warming System of Premature Ovarian Insufficiency

• Conditions: Primary Ovarian Insufficiency

• Registration Number: NCT03518944
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Status Verified: 2017-08
• Study First Submitted: 2018-03-28
• Study First Submitted QC: 2018-04-25
• Last Update Submitted: 2018-04-25
• Study First Posted: 2018-05-08
• Last Update Posted: 2018-05-08
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 500

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of menstruation situation	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	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	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	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

Trial Locations

Locations (1)

Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China