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

Primary Ovarian Insufficiency Clinical Trial

Official title:

Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women： Multi-center, Prospective,Observational Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518918
• Other study ID #: NFEC-2016-141
• Status: Recruiting
• Start date: September 1, 2016
• Est. completion date: December 1, 2021

Study information

• Verified date: May 2017
• Source: Nanfang Hospital of Southern Medical University
• Contact: Shi-ling Chen, M.D, Ph.D
• Phone: +86-020-62787604
• Email: chensl_92[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to establishing the diagnosis standard of POI and analyzing the risk factors in Chinese women.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50000
• Est. completion date: December 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 39 Years

Eligibility

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

Related Conditions & MeSH terms

• Gonadal Dysgenesis
• Menopause, Premature
• Primary Ovarian Insufficiency
• Turner Syndrome

Locations

Country	Name	City	State
China	Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University	Guangzhou	Guangdong

Sponsors (7)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University	Guangdong Provincial Hospital of Traditional Chinese Medicine, Queen Mary Hospital, Hong Kong, Shen-Zhen City Maternity and Child Healthcare Hospital, Shenzhen Hospital of Southern Medical University, Southern Medical University, China, The Third Affiliated Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of serum FSH levels	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.	through study completion, an average of 3 months, assessed up to 48 months
Primary	Menstruation situation	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.	through study completion, an average of 3 months, assessed up to 48 months
Secondary	Change of Antral follicle count	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.	through study completion, an average of 3 months, assessed up to 48 months
Secondary	Change of anti-mullerian hormone levels	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.	through study completion, an average of 3 months, assessed up to 48 months