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NCT Number: NCT07723443

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

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.

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Key information

Conditions

PCOS (Polycystic Ovary Syndrome) Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gonadal Disorders Neoplasms Ovarian Cysts Ovarian Diseases Polycystic Ovary Syndrome Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kamal Al-Samarrai Specialized Hospital

Baghdad, Al-Rusafa, 10064, Iraq

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vitamin E 400

Dietary Supplement

Soft gelatin capsule of Vitamin E each contains 400 IU

Folic Acid 5 Mg Oral Tablet

Dietary Supplement

Film coated tablet of 5 mg folic acid

Primary outcomes

  1. Ezrin

    Time frame: At baseline after one month of treatment

    Serum levels of Ezrin

  2. Follicle-stimulating hormone

    Time frame: At baseline and after one month of treatment

    Serum levels of follicle-stimulating hormone

  3. Luteinizing hormone

    Time frame: At baseline after one month of treatment

    Serum levels of luteinizing hormone

  4. Prolactin

    Time frame: At baseline after one month of treatment

    Serum levels of prolactin hormone

  5. Estradiol

    Time frame: At baseline after one month of treatment

    Serum levels of estradiol hormone

  6. Thyroid-stimulating hormone

    Time frame: At baseline after one month of treatment

    Serum levels of thyroid-stimulating hormone

  7. Total testosterone

    Time frame: At baseline after one month of treatment

    Serum levels of total testosterone

  8. Sex hormone-binding globulin

    Time frame: At baseline after one month of treatment

    Serum levels of sex hormone-binding globulin

Sponsors and collaborators

Lead sponsor

Al-Mustansiriyah University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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