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

Last updated: November 10, 2023
Sponsor: International Peace Maternity and Child Health Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Perimenopause

Female Hormonal Deficiencies/abnormalities

Treatment

N/A

Clinical Study ID

NCT06121388
GFY2023007
  • Ages 18-40
  • Female
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 casecontrol 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

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 scanningcontraindications;
  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, haveother cognitive-impacting diseases, or serious somatic diseases such as malignanttumors, acute heart failure, multi-organ failure, and so on.

Study Design

Total Participants: 100
Study Start date:
January 01, 2023
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • The International Peace Maternity and Child Health Hospital

    Shanghai, Shanghai 200030
    China

    Active - Recruiting

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