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NCT07723443Completed

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

Effects of Folic Acid and Vitamin E on Serum Ezrin and Hormonal Profile in Women With Polycystic Ovary Syndrome

Source: ClinicalTrials.gov · Last updated 23 Jul 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Interventional
Enrollment
207 (actual)
First submitted
19 Jul 2026
Start date
1 Jul 2025
Primary completion date
10 Feb 2026
Lead sponsor
Al-Mustansiriyah University
NCT number
NCT07723443

What you commit to

  • Study type: Interventional
  • Participants enrolled: 207
  • From 1 Jul 2025 to the primary completion date, 10 Feb 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Patients with other endocrine disorders that could affect hormonal status, pregnancy, or recent use of hormonal or antioxidant therapy before enrollment

Who the study is looking for

  • Women of reproductive age with confirmed PCOS who presented with primary or secondary infertility

Age in the registry: 18 years to - · Sex: Female · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Kamal Al-Samarrai Specialized Hospital
Coordinator of this site? Confirm its status
BaghdadIraqUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.