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

NCT03518918 | Unknown

• 1 other identifier: NFEC-2016-141
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Ovarian Insufficiency

Keywords

Premature ovarian insufficiency; Diagnosis standard; Risk factors

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Change of Antral follicle count

  through study completion, an average of 3 months, assessed up to 48 months

• Change of anti-mullerian hormone levels

  through study completion, an average of 3 months, assessed up to 48 months

Eligibility Criteria

• Age: 12 Years - 39 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Female under the condition of diminished ovarian reserve were enrolled in the study. The condition of diminished ovarian reserve may be the early stage of premature ovarian insufficiency.

You may qualify if:

• 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

You may not qualify if:

• Polycystic Ovarian Syndrome
• other causes of amenorrhea

Sponsors & Collaborators

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

Study Sites (1)

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

Guangzhou, Guangdong, 510515, China

RECRUITING

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

• Shi-ling Chen, M.D, Ph.D

  Nanfang Hospital, Southern Medical University

  STUDY CHAIR

Central Study Contacts

Shi-ling Chen, M.D, Ph.D

CONTACT

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

Study Design

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

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: May 8, 2018
• Study Start: September 1, 2016
• Primary Completion: September 1, 2021
• Study Completion: December 1, 2021
• Last Updated: May 8, 2018

Record last verified: 2017-05

Locations

CN (1)