PCOS (Polycystic Ovary Syndrome)
Conditions
Keywords
Polycystic ovary syndrome, Ezrin, Vitamin E, Folic acid, Hormonal profile, Free androgen index
Brief summary
The goal of this prospective comparative interventional study is to evaluate serum Ezrin levels and investigate the effects of one-month supplementation with vitamin E and folic acid in Iraqi women of reproductive age diagnosed with polycystic ovary syndrome (PCOS) evaluating for infertility, as well as healthy controls. The main questions it aims to answer are: * Do serum Ezrin levels differ between women with PCOS and healthy controls, and do these levels change following intervention? * What impact does one-month supplementation with vitamin E, folic acid, or their combination have on hormonal profiles (such as LH, FSH, testosterone, and SHBG) and clinical symptoms? If there is a comparison group: Researchers will compare three PCOS treatment arms (vitamin E 400 IU/day, folic acid 5 mg/day, and a combination of both) to each other and to a baseline healthy control group to see if the interventions partially improve androgen bioavailability, reproductive hormonal balance, clinical symptoms like hirsutism, and whether they modulate circulating serum Ezrin levels. Participants will: * Take their assigned daily oral intervention (vitamin E, folic acid, or a combination of the two) for a duration of one month. * Provide venous blood samples before treatment begins and after the one-month period to measure serum Ezrin concentrations and reproductive hormones. * Undergo clinical and anthropometric assessments to document variables including body mass index (BMI), waist-to-hip ratio (WHR), blood pressure, acne, hirsutism, and menstrual cycle regularity.
Interventions
DIETARY_SUPPLEMENTVitamin E 400
Soft gelatin capsule of Vitamin E each contains 400 IU
DIETARY_SUPPLEMENTFolic Acid 5 Mg Oral Tablet
Film coated tablet of 5 mg folic acid
Sponsors
Al-Mustansiriyah University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility
Exclusion criteria
* Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ezrin | At baseline after one month of treatment | Serum levels of Ezrin |
| Follicle-stimulating hormone | At baseline and after one month of treatment | Serum levels of follicle-stimulating hormone |
| Luteinizing hormone | At baseline after one month of treatment | Serum levels of luteinizing hormone |
| Prolactin | At baseline after one month of treatment | Serum levels of prolactin hormone |
| Estradiol | At baseline after one month of treatment | Serum levels of estradiol hormone |
| Thyroid-stimulating hormone | At baseline after one month of treatment | Serum levels of thyroid-stimulating hormone |
| Total testosterone | At baseline after one month of treatment | Serum levels of total testosterone |
| Sex hormone-binding globulin | At baseline after one month of treatment | Serum levels of sex hormone-binding globulin |
Countries
Iraq
Outcome results
None listed