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Establishing of an Early Warming System of Premature Ovarian Insufficiency

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ClinicalTrials.gov Identifier: NCT03518944
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : May 8, 2018
Sponsor:
Information provided by (Responsible Party):
Nanfang Hospital of Southern Medical University

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.

Condition or disease
Primary Ovarian Insufficiency

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: Establishing of an Early Warming System of Premature Ovarian Insufficiency
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : July 1, 2021


Group/Cohort
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



Primary Outcome Measures :
  1. the change of serum follicle-stimulating hormone levels [ Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months ]
    the serum FSH levels between day 2 to day 5 of menstrual cycle

  2. the change of menstruation situation [ Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months ]
    Menstrual cycle

  3. the change of serum anti-mullerian hormone levels [ Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months ]
    the serum anti-mullerian hormone levels between day 2 to day 5 of menstrual cycle

  4. the change of antral follicle count [ Time Frame: Every 3 months from date of recruit until the date of study completion, assessed up to 48 months ]
    Antral follicle count between day 2 to day 5 of menstrual cycle


Biospecimen Retention:   Samples Without DNA
blood plasma


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Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients of occult premature ovarian insufficiency
Criteria

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

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): NCT03518944


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

Locations
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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
Investigators
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Study Chair: Shiling Chen, M.D./Ph.D. Nanfang Hospital of Southern Medical University

Additional Information:

Publications:
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Responsible Party: Nanfang Hospital of Southern Medical University
ClinicalTrials.gov Identifier: NCT03518944     History of Changes
Other Study ID Numbers: NFEC-2017-197
First Posted: May 8, 2018    Key Record Dates
Last Update Posted: May 8, 2018
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Ovarian Insufficiency
Gonadal Dysgenesis
Ovarian Diseases
Urogenital Abnormalities
Congenital Abnormalities
Cardiovascular Abnormalities
Menopause, Premature
Turner Syndrome
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
Disorders of Sex Development
Sex Chromosome Disorders of Sex Development
Heart Defects, Congenital
Cardiovascular Diseases
Heart Diseases
Sex Chromosome Disorders
Chromosome Disorders
Genetic Diseases, Inborn