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

NCT ID: NCT06121388

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2025-12-31

Brief Summary

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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

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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.

Conditions

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Premature Ovarian Failure

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

premature ovarian failure group

Patients are diagnosed with premature ovarian failure.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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International Peace Maternity and Child Health Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dongmei Lai

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dongmei Lai, M.D.

Role: PRINCIPAL_INVESTIGATOR

The International Peace Maternity and Child Health Hospital

Locations

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The International Peace Maternity and Child Health Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Dongmei Lai, M.D.

Role: CONTACT

86-021-64070434 ext. 27701

Facility Contacts

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Dongmei Lai, M.D

Role: primary

86-21-64070434-27701

Qian Wang, pH.D

Role: backup

86-21-64070434-27721

References

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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.

Reference Type BACKGROUND
PMID: 37423941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30326011 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11554798 (View on PubMed)

Other Identifiers

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GFY2023007

Identifier Type: -

Identifier Source: org_study_id

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