Establishing the Diagnosis Standard and Analysis the Risk Factors of POI in Chinese Women

• Conditions: Primary Ovarian Insufficiency

• Registration Number: NCT03518918
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2016-09-01
• Status Verified: 2017-05
• Study First Submitted: 2017-06-13
• 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: 2021-09-01
• Study Completion: 2021-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

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