Brain MRI Imaging Changes and Associated Factors on Cognition Function in Patients With Premature Ovarian Failure
International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
1 other identifier
observational
100
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2023
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
November 2, 2023
CompletedFirst Posted
Study publicly available on registry
November 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 14, 2023
November 1, 2023
2.7 years
November 2, 2023
November 10, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brain structure
Brain structure will be assessed by MRI.
1 year
Secondary Outcomes (6)
Follicle-stimulating hormone (FSH) serum level
1 year
Luteinizing hormone (LH) serum level
1 year
Estradiol (E2) serum level
1 year
Testosterone (T) serum level
1 year
Prolactin (PRL) serum level
1 year
- +1 more secondary outcomes
Study Arms (2)
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.
premature ovarian failure group
Patients are diagnosed with premature ovarian failure.
Eligibility Criteria
50 premature ovarian failure patients of age 18-40 treated in the International Peace Maternity and Child Health Hospital. 50 women with similar age, BMI, working environment, education level and regular menstrual cycle in our hospital, and conduct endocrine examination for health examination.
You may qualify if:
- \. 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. 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030, China
Related 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.
PMID: 37423941BACKGROUNDZeydan 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.
PMID: 30326011BACKGROUNDMaki 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.
PMID: 11554798BACKGROUND
Biospecimen
Serm
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dongmei Lai, M.D.
The International Peace Maternity and Child Health Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
November 2, 2023
First Posted
November 7, 2023
Study Start
January 1, 2023
Primary Completion
September 1, 2025
Study Completion
December 31, 2025
Last Updated
November 14, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 2 years
- Access Criteria
- Public
The public can require the data and protocol from clinicaltrials.gov posted by investigator.