International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Premature Ovarian Failure
- Sponsor
- International Peace Maternity and Child Health Hospital
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Brain structure
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Dongmei Lai
Principal Investigator
International Peace Maternity and Child Health Hospital
Eligibility Criteria
Inclusion Criteria
- •Criteria for premature ovarian failure:
- •Subjects must meet all the following criteria to be included in the study:
- •Female, between 18 and 40 years old;
- •FSH ≥ 40U/L on two occasions at least four weeks;
- •Sign informed consent.
- •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
- •Pregnancy or lactation;
- •Patients with secondary ovarian insufficiency (such as causes of the hypothalamus);
- •Chromosomal karyotype abnormalities (such as Turner syndrome, brittle X syndrome);
- •Any disease that requires immediate blood transfusion;
- •Abuse of alcohol, drugs or drugs (for example, laxatives)
- •Allergies to MRI contrast agents;
- •Accompanied by metal implants, claustrophobia and other magnetic resonance scanning contraindications;
- •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.
Outcomes
Primary Outcomes
Brain structure
Time Frame: 1 year
Brain structure will be assessed by MRI.
Secondary Outcomes
- Testosterone (T) serum level(1 year)
- Prolactin (PRL) serum level(1 year)
- Anti-müllerian hormone (AMH) serum level(1 year)
- Follicle-stimulating hormone (FSH) serum level(1 year)
- Luteinizing hormone (LH) serum level(1 year)
- Estradiol (E2) serum level(1 year)