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Completed NCT07723443

Effects of Folic Acid and Vitamin E on Hormones in Polycystic Ovary Syndrome

Conditions: PCOS (Polycystic Ovary Syndrome)

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 207
Sponsor: Al-Mustansiriyah University

Location: Kamal Al-Samarrai Specialized Hospital Baghdad Al-Rusafa

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.

Eligibility Criteria

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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07723443). StuddyBuddy aggregates publicly available trial information.