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Identification of brain function abnormalities and verification of structural connection mechanisms in polycystic ovary syndrome based on near-infrared functional screening

Identification of brain function abnormalities and verification of structural connection mechanisms in polycystic ovary syndrome based on near-infrared functional screening

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500108055
Enrollment
Unknown
Registered
2025-08-25
Start date
2025-08-29
Completion date
Unknown
Last updated
2025-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic ovary syndrome

Interventions

two:NA

Sponsors

The First Affiliated Hospital of Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Age: 18-40 years old, excluding women during menopause or pregnancy to ensure the relative consistency of endocrine and physiological characteristics. 2. PCOS Diagnosis: Meet the World Health Organization (WHO) or American College of Obstetricians and Gynecologists (ACOG) diagnostic criteria for PCOS. At least two of the following three are met: Irregular periods (long cycles or anovulatory menstruation). Hyperandrogenism (clinical or biochemical manifestations such as hirsutism, acne, male pattern baldness, etc.). Ultrasonography shows polycystic ovarian manifestations (at least 12 follicles >2 to 9 mm, or increased ovarian size) 3. No other major disciplinary diseases: including severe mental disorders (such as depression, schizophrenia, etc.), neurological diseases (such as epilepsy, cerebrovascular diseases, etc.). 4. No drug effects: No drugs that affect endocrine levels (such as birth control pills, antiandrogen drugs, etc.) have not been taken within six months before the study. 5. No pregnancy or lactation: Do not become pregnant or lactate during the study period to avoid interference with the study results caused by fluctuations in hormone levels. 6. Lifestyle consistency: No history of drug or alcohol abuse, and no major lifestyle changes that affect brain function (such as extreme diet or excessive exercise, etc.). 7. Informed consent: voluntarily participate, understand and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Severe mental illness: Any diagnosed mental illness such as major depressive disorder, schizophrenia, bipolar disorder, major anxiety disorder, obsessive-compulsive disorder, etc. Patients with a psychiatric episode in the last 3 months. Patients who are receiving psychotropic medication (e.g., antidepressants, antipsychotics, etc.). 2. Neurological disorders: Any known neurodegenerative disease (such as Alzheimer's disease, Parkinson's disease, etc.). Epilepsy or other types of seizures. Other neurological diseases that affect brain function (such as stroke, sequelae of traumatic brain injury, etc.). 3. Severe endocrine diseases: Any thyroid disease (such as hyperthyroidism, hypothyroidism, etc.), especially if not controlled by treatment. Other serious endocrine disorders, such as adrenal cortical dysfunction, pituitary disease, etc. 4. Drug effects: Use of drugs that may affect endocrine levels, such as oral contraceptives, antiandrogen drugs, ovulation induction drugs (such as clomiphene), etc. within six months before the study. Has used central nervous system medications (such as antidepressants, anxiolytics, sedative-hypnotics, etc.). 5. Pregnancy or lactation: Participants were pregnant or breastfeeding because these physiological states significantly altered hormone levels and brain activity, potentially interfering with experimental results. 6. Uncontrolled metabolic disease: Such as diabetes (especially type 1 diabetes), especially uncontrolled conditions can affect physical health and cognitive function. 7. Severe weight problems: Body mass index (BMI) that is too high (>=40, obese) or too low (<18.5, underweight) may affect brain function and neuroimaging data. 8. Ophthalmic problems: Ocular diseases such as retinopathy or severe refractive errors may affect the collection of fNIRS signals. 9. Other reasons why fNIRS measurement is not appropriate: Participants were unable to complete the fNIRS experimental task, possibly due to factors such as excessive anxiety, fear of enclosed spaces, migraines, etc. 10. Language and Cultural Barriers: Individuals who do not have sufficient language skills (e.g., do not know the language of study) or whose cultural background does not allow them to understand task instructions.

Design outcomes

Primary

MeasureTime frame
The activation level of brain regions;Functional connectivity;Brain network pattern;The spatiotemporal characteristics of brain activity;

Secondary

MeasureTime frame
The reaction time of the participants;

Countries

China

Contacts

Public ContactChuyan Wu

The First Affiliated Hospital of Nanjing Medical University

chuyan_w@hotmail.com+86 138 1396 1932

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026