Establishing of an Early Warming System of Premature Ovarian Insufficiency

NCT03518944 | Unknown

• 1 other identifier: NFEC-2017-197
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Primary Ovarian Insufficiency

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Study Arms (1)

occult premature ovarian insufficiency

Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

patients of occult premature ovarian insufficiency

You may qualify if:

• Serum FSH levels ≥10mIU/ml/ serum AMH levels ≤1.0pg/ml/ AFC ≤5, on at least two occasion \>4 weeks apart

You may not qualify if:

• Polycystic Ovarian Syndrome
• other causes of amenorrhea

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead

Study Sites (1)

Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, 510515, China

RECRUITING

Related 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.

  PMID: 27008889 BACKGROUND

• 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.

  PMID: 17970776 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood plasma

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Shiling Chen, M.D./Ph.D.

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Shiling Chen, M.D./Ph.D.

CONTACT

+86-020-62787604; chensl_92@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2018
• First Posted: May 8, 2018
• Study Start: July 1, 2017
• Primary Completion: December 31, 2020
• Study Completion: July 1, 2021
• Last Updated: May 8, 2018

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)