Establishing of an Early Warming System of Premature Ovarian Insufficiency

April 25, 2018 updated by: Nanfang Hospital of Southern Medical University
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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Shiling Chen, M.D./Ph.D.
  • Phone Number: +86-020-62787604
  • Email: chensl_92@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510515
        • Recruiting
        • Center for Reproductive Medicine, Department of Gynecology and Obstetrics, Nanfang Hospital, Southern Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 40 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

patients of occult premature ovarian insufficiency

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
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
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
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
Every 3 months from date of recruit until the date of study completion, assessed up to 48 months
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
Every 3 months from date of recruit until the date of study completion, assessed up to 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital of Southern Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

July 1, 2021

Study Registration Dates

First Submitted

March 28, 2018

First Submitted That Met QC Criteria

April 25, 2018

First Posted (ACTUAL)

May 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NFEC-2017-197

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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