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

Recruiting

• Conditions: Premature Ovarian Failure

• Registration Number: NCT06121388
• Lead Sponsor: International Peace Maternity and Child Health Hospital

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.

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 Timeline

• Study Start: 2023-01-01
• Status Verified: 2023-11
• Study First Submitted: 2023-11-02
• Study First Submitted QC: 2023-11-02
• Study First Posted: 2023-11-07
• Last Update Submitted: 2023-11-10
• Last Update Posted: 2023-11-14
• Primary Completion: 2025-09-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Brain structure	1 year	Brain structure will be assessed by MRI.

Secondary Outcome Measures

Name	Time	Method
Prolactin (PRL) serum level	1 year	Prolactin (PRL) serum level will be tested.
Anti-müllerian hormone (AMH) serum level	1 year	Anti-müllerian hormone (AMH) serum level will be tested.
Testosterone (T) serum level	1 year	Testosterone (T) serum level will be tested.
Follicle-stimulating hormone (FSH) serum level	1 year	Follicle-stimulating hormone (FSH) serum level will be tested.
Luteinizing hormone (LH) serum level	1 year	Luteinizing hormone (LH) serum level will be tested.
Estradiol (E2) serum level	1 year	Estradiol (E2) serum level will be tested.

Trial Locations

Locations (1)

The International Peace Maternity and Child Health Hospital; 🇨🇳 Shanghai, Shanghai, China