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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06121388
Other study ID # GFY2023007
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source International Peace Maternity and Child Health Hospital
Contact Dongmei Lai, M.D.
Phone 86-021-64070434
Email laidongmei@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date December 31, 2025
Est. primary completion date September 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Locations

Country Name City State
China The International Peace Maternity and Child Health Hospital Shanghai Shanghai

Sponsors (1)

Lead Sponsor Collaborator
International Peace Maternity and Child Health Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Brown A, Gervais NJ, Rieck J, Almey A, Gravelsins L, Reuben R, Karkaby L, Rajah MN, Grady C, Einstein G. Women's Brain Health: Midlife Ovarian Removal Affects Associative Memory. Mol Neurobiol. 2023 Nov;60(11):6145-6159. doi: 10.1007/s12035-023-03424-6. Epub 2023 Jul 10. — View Citation

Maki PM, Resnick SM. Effects of estrogen on patterns of brain activity at rest and during cognitive activity: a review of neuroimaging studies. Neuroimage. 2001 Oct;14(4):789-801. doi: 10.1006/nimg.2001.0887. — View Citation

Zeydan B, Tosakulwong N, Schwarz CG, Senjem ML, Gunter JL, Reid RI, Gazzuola Rocca L, Lesnick TG, Smith CY, Bailey KR, Lowe VJ, Roberts RO, Jack CR Jr, Petersen RC, Miller VM, Mielke MM, Rocca WA, Kantarci K. Association of Bilateral Salpingo-Oophorectomy Before Menopause Onset With Medial Temporal Lobe Neurodegeneration. JAMA Neurol. 2019 Jan 1;76(1):95-100. doi: 10.1001/jamaneurol.2018.3057. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Brain structure Brain structure will be assessed by MRI. 1 year
Secondary Follicle-stimulating hormone (FSH) serum level Follicle-stimulating hormone (FSH) serum level will be tested. 1 year
Secondary Luteinizing hormone (LH) serum level Luteinizing hormone (LH) serum level will be tested. 1 year
Secondary Estradiol (E2) serum level Estradiol (E2) serum level will be tested. 1 year
Secondary Testosterone (T) serum level Testosterone (T) serum level will be tested. 1 year
Secondary Prolactin (PRL) serum level Prolactin (PRL) serum level will be tested. 1 year
Secondary Anti-müllerian hormone (AMH) serum level Anti-müllerian hormone (AMH) serum level will be tested. 1 year
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