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Trial record 12 of 26 for:    Premature | Recruiting, Not yet recruiting, Available Studies | "Primary Ovarian Insufficiency"

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

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ClinicalTrials.gov Identifier: NCT03518918
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Collaborators:
Queen Mary Hospital, Hong Kong
Southern Medical University, China
The Third Affiliated Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University
Shen-Zhen City Maternity and Child Healthcare Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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

Condition or disease
Primary Ovarian Insufficiency

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 Type : Observational
Estimated Enrollment : 50000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Establishing the Diagnosis Standard and Analysis the Risk Factors of Premature Ovarian Insufficiency in Chinese Women: Multi-center, Prospective,Observational Study
Actual Study Start Date : September 1, 2016
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : December 1, 2021





Primary Outcome Measures :
  1. Change of serum FSH levels [ Time Frame: 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.

  2. Menstruation situation [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change of Antral follicle count [ Time Frame: 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.

  2. Change of anti-mullerian hormone levels [ Time Frame: 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.



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Ages Eligible for Study:   12 Years to 39 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03518918


Contacts
Contact: Shi-ling Chen, M.D, Ph.D +86-020-62787604 chensl_92@163.com

Locations
China, Guangdong
Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University Recruiting
Guangzhou, Guangdong, China, 510515
Contact: Shi-Ling Chen, M.D., Ph.D.    +86-20-62787604    chensl_92@163.com   
Principal Investigator: Shi-Ling Chen, M.D., Ph.D.         
Sponsors and Collaborators
Nanfang Hospital of Southern Medical University
Queen Mary Hospital, Hong Kong
Southern Medical University, China
The Third Affiliated Hospital of Southern Medical University
Shenzhen Hospital of Southern Medical University
Shen-Zhen City Maternity and Child Healthcare Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
Study Chair: Shi-ling Chen, M.D, Ph.D Nanfang Hospital of Southern Medical University

Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03518918     History of Changes
Other Study ID Numbers: NFEC-2016-141
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: May 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nanfang Hospital of Southern Medical University:
Premature ovarian insufficiency
Diagnosis standard
Risk factors

Additional relevant MeSH terms:
Primary Ovarian Insufficiency
Menopause, Premature
Gonadal Dysgenesis
Turner Syndrome
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn