Brain MRI Imaging Changes and Associated Factors on Cognition Function in Patients With Premature Ovarian Failure

November 10, 2023 updated by: Dongmei Lai, International Peace Maternity and Child Health Hospital

International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China

The purpose of this study is to investigate the brain MRI imaging changes and associated factors on cognition function in patients with premature ovarian failure.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Premature Ovarian Failure (POF) refers to a disease characterized by amenorrhea, infertility, low estrogen levels, and high gonadotropin concentration in women before the age of 40. In recent years, the incidence has shown a significant increase. The average age of POF in China is 28.9 years old, involving 2 million women of childbearing age. POF patients have significant emotional disorders and cognitive changes, but it is not known whether the structure and function of the POF patients' brain have changed. It is known that the perimenopause (i.e. estrogen decline) may be the early stage of AD. Therefore, this study aims to use brain imaging technology to explore the changes of brain injury in POF patients with the progression of the disease to achieve early assessment of AD in POF patients. The research work of this project is mainly based on multimodal magnetic resonance imaging technology. For the clinical phenomenon of brain dysfunction in POF patients, it analyzes the changes in brain structure and brain function of POF patients for the first time. Using artificial intelligence brain network analysis method, from the perspective of brain structure and brain function, to determine whether there is microstructural transformation of white matter in POF patients and whether it is related to disease progression and serological indicators. Through the implementation of this project, it provides a basis for brain structure and functional changes for the diagnosis and treatment of POF, and provides a basis for large-scale clinical research to guide clinical formulation of reasonable diagnosis and treatment plans and prognosis evaluation.

Study Type

Observational

Enrollment (Estimated)

100

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

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Recruiting
        • The International Peace Maternity and Child Health Hospital
        • Contact:
        • Contact:
          • Qian Wang, pH.D
          • Phone Number: 86-21-64070434-27721
          • Email: PAULIA@163.COM

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

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

50 premature ovarian failure patients of age 18-40 treated in the International Peace Maternity and Child Health Hospital. 50 women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination.

Description

Inclusion Criteria:

1. Criteria for premature ovarian failure:

  1. Subjects must meet all the following criteria to be included in the study:
  2. Female, between 18 and 40 years old;
  3. FSH ≥ 40U/L on two occasions at least four weeks;
  4. Sign informed consent. 2. Criteria for the health control group: According to the case control principle, at the same time, the investigators select women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination (FSH <10U/L) for health examination.

Exclusion Criteria:

  1. Pregnancy or lactation;
  2. Patients with secondary ovarian insufficiency (such as causes of the hypothalamus);
  3. Chromosomal karyotype abnormalities (such as Turner syndrome, brittle X syndrome);
  4. Any disease that requires immediate blood transfusion;
  5. Abuse of alcohol, drugs or drugs (for example, laxatives)
  6. Allergies to MRI contrast agents;
  7. Accompanied by metal implants, claustrophobia and other magnetic resonance scanning contraindications;
  8. Accompanied by serious brain organic diseases, such as epilepsy, stroke, encephalitis, brain trauma, and so on. Nervous system diseases, such as Parkinson's disease, have other cognitive-impacting diseases, or serious somatic diseases such as malignant tumors, acute heart failure, multi-organ failure, and so on.

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
health control group
Health control women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination.
premature ovarian failure group
Patients are diagnosed with premature ovarian failure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain structure
Time Frame: 1 year
Brain structure will be assessed by MRI.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Follicle-stimulating hormone (FSH) serum level
Time Frame: 1 year
Follicle-stimulating hormone (FSH) serum level will be tested.
1 year
Luteinizing hormone (LH) serum level
Time Frame: 1 year
Luteinizing hormone (LH) serum level will be tested.
1 year
Estradiol (E2) serum level
Time Frame: 1 year
Estradiol (E2) serum level will be tested.
1 year
Testosterone (T) serum level
Time Frame: 1 year
Testosterone (T) serum level will be tested.
1 year
Prolactin (PRL) serum level
Time Frame: 1 year
Prolactin (PRL) serum level will be tested.
1 year
Anti-müllerian hormone (AMH) serum level
Time Frame: 1 year
Anti-müllerian hormone (AMH) serum level will be tested.
1 year

Collaborators and Investigators

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

Sponsor

International Peace Maternity and Child Health Hospital

Investigators

  • Principal Investigator: Dongmei Lai, M.D., The International Peace Maternity and Child Health Hospital

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)

January 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

November 2, 2023

First Submitted That Met QC Criteria

November 2, 2023

First Posted (Actual)

November 7, 2023

Study Record Updates

Last Update Posted (Estimated)

November 14, 2023

Last Update Submitted That Met QC Criteria

November 10, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GFY2023007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The public can require the data and protocol from clinicaltrials.gov posted by investigator.

IPD Sharing Time Frame

2 years

IPD Sharing Access Criteria

Public

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

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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