Establishing of an Early Warming System of Premature Ovarian Insufficiency

Primary Ovarian Insufficiency Clinical Trial

Official title:

Establishing of an Early Warming System of Premature Ovarian Insufficiency

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03518944
• Other study ID #: NFEC-2017-197
• Status: Recruiting
• Start date: July 1, 2017
• Est. completion date: July 1, 2021

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 1, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 40 Years

Eligibility

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

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 (1)

Lead Sponsor	Collaborator
Nanfang Hospital of Southern Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

Welt CK. Primary ovarian insufficiency: a more accurate term for premature ovarian failure. Clin Endocrinol (Oxf). 2008 Apr;68(4):499-509. Epub 2007 Oct 29. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the change of serum follicle-stimulating hormone levels	the serum FSH levels between day 2 to day 5 of menstrual cycle	Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Primary	the change of menstruation situation	Menstrual cycle	Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Primary	the change of serum anti-mullerian hormone levels	the serum anti-mullerian hormone levels between day 2 to day 5 of menstrual cycle	Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
Primary	the change of antral follicle count	Antral follicle count between day 2 to day 5 of menstrual cycle	Every 3 months from date of recruit until the date of study completion, assessed up to 48 months