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临床试验/NCT07058675
NCT07058675已完成不适用

Myoinositol Therapy May Adjust The Metabolic Deregulation in Infertile Polycystic Ovarian Syndrome (PCOS) Women Through Modulation of The TyG Index-BMI: A Comparative Study Versus Metformin

Benha University1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年11月25日最近更新:
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
156
试验地点
1
主要终点
Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy

研究概览

简要总结

The study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Participants were divided into two groups, receiving either metformin or a myoinositol/d-chiro-inositol combination for six months, after which all parameters were re-evaluated to determine the percentage of change.

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
23 Years 至 47 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients presenting manifestations suggestive of having PCOS;
  • Patients were free of exclusion criteria.

排除标准

  • Patients who were maintained on a diet regimen, or/and regular exercise;
  • Patients who were on medical therapy of PCOS, antidiabetic or/and antihypertensive therapy;
  • Patients who underwent laparoscopic drilling;
  • Patients with dyslipidemia, hereditary lipoprotein disorders:
  • Patients with chronic liver or kidney diseases.

研究组 & 干预措施

Myoinositol Group

Active Comparator

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took the tablets containing myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio

干预措施: Myoinositol (Drug)

Metformin Group

Active Comparator

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg

干预措施: Metformin Hydrochloride 500 MG (Drug)

结局指标

主要结局

Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy

时间窗: 6~7 Months

The proportion of patients who regained a regular menstrual pattern and/or achieved pregnancy during the study, reflecting the effectiveness of the administered treatment regimens.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Basma Sakr

Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Benha University

研究点 (1)

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