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临床试验/NCT07723443
NCT07723443已完成不适用

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

Al-Mustansiriyah University1 个研究点 分布在 1 个国家目标入组 207 人开始时间: 2025年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
207
试验地点
1
主要终点
Ezrin

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Ezrin

时间窗: At baseline after one month of treatment

Serum levels of Ezrin

Follicle-stimulating hormone

时间窗: At baseline and after one month of treatment

Serum levels of follicle-stimulating hormone

Luteinizing hormone

时间窗: At baseline after one month of treatment

Serum levels of luteinizing hormone

Prolactin

时间窗: At baseline after one month of treatment

Serum levels of prolactin hormone

Estradiol

时间窗: At baseline after one month of treatment

Serum levels of estradiol hormone

Thyroid-stimulating hormone

时间窗: At baseline after one month of treatment

Serum levels of thyroid-stimulating hormone

Total testosterone

时间窗: At baseline after one month of treatment

Serum levels of total testosterone

Sex hormone-binding globulin

时间窗: At baseline after one month of treatment

Serum levels of sex hormone-binding globulin

次要结局

未报告次要终点

研究者

发起方
Al-Mustansiriyah University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Huda Jaber Waheed

Head of Department

Al-Mustansiriyah University

研究点 (1)

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