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

Sponsor
International Peace Maternity and Child Health Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT06121388
Collaborator
(none)
100
1
36
2.8

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    100 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
    Actual Study Start Date :
    Jan 1, 2023
    Anticipated Primary Completion Date :
    Sep 1, 2025
    Anticipated Study Completion Date :
    Dec 31, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Brain structure [1 year]

      Brain structure will be assessed by MRI.

    Secondary Outcome Measures

    1. Follicle-stimulating hormone (FSH) serum level [1 year]

      Follicle-stimulating hormone (FSH) serum level will be tested.

    2. Luteinizing hormone (LH) serum level [1 year]

      Luteinizing hormone (LH) serum level will be tested.

    3. Estradiol (E2) serum level [1 year]

      Estradiol (E2) serum level will be tested.

    4. Testosterone (T) serum level [1 year]

      Testosterone (T) serum level will be tested.

    5. Prolactin (PRL) serum level [1 year]

      Prolactin (PRL) serum level will be tested.

    6. Anti-müllerian hormone (AMH) serum level [1 year]

      Anti-müllerian hormone (AMH) serum level will be tested.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    1. Criteria for premature ovarian failure:

    2. Subjects must meet all the following criteria to be included in the study:

    3. Female, between 18 and 40 years old;

    4. FSH ≥ 40U/L on two occasions at least four weeks;

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The International Peace Maternity and Child Health Hospital Shanghai Shanghai China 200030

    Sponsors and Collaborators

    • International Peace Maternity and Child Health Hospital

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dongmei Lai, Principal Investigator, International Peace Maternity and Child Health Hospital
    ClinicalTrials.gov Identifier:
    NCT06121388
    Other Study ID Numbers:
    • GFY2023007
    First Posted:
    Nov 7, 2023
    Last Update Posted:
    Nov 14, 2023
    Last Verified:
    Nov 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Dongmei Lai, Principal Investigator, International Peace Maternity and Child Health Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 14, 2023