Investigating brain changes and cognition in women with premature ovarian failure
International Peace Maternity and Child Health Hospital (IPMCH) Affiliated to School of Medicine, Shanghai Jiaotong University, Shanghai, China
This study is trying to see how premature ovarian failure affects the brain and thinking skills in women under 40 by using advanced brain scans.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | International Peace Maternity and Child Health Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06121388 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the brain MRI imaging changes and cognitive function in women diagnosed with premature ovarian failure (POF). POF is characterized by early onset amenorrhea, infertility, and hormonal imbalances, affecting women under 40. The research utilizes advanced multimodal magnetic resonance imaging technology to assess structural and functional brain changes in POF patients, potentially linking these changes to disease progression and cognitive decline. By employing artificial intelligence for brain network analysis, the study seeks to provide insights into the relationship between brain health and POF, contributing to early diagnosis and treatment strategies.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 40 who have been diagnosed with premature ovarian failure.
Not a fit: Patients who are pregnant, lactating, or have secondary ovarian insufficiency or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of cognitive decline in women with premature ovarian failure.
How similar studies have performed: While this approach is innovative, similar studies have shown promising results in understanding cognitive changes associated with hormonal fluctuations, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Shanghai, Shanghai
- The International Peace Maternity and Child Health Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Dongmei Lai, M.D. — The International Peace Maternity and Child Health Hospital
- Study coordinator: Dongmei Lai, M.D.
- Email: laidongmei@hotmail.com
- Phone: 86-021-64070434
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.