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临床试验/NCT01622257
NCT01622257已完成2 期

Comparison of Cavitation Ultrasound, Metformin or the Combination of Both in Obese Women With Polycystic Ovary Syndrome

Ain Shams University1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2011年6月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
198
试验地点
1
主要终点
Clinical Pregnancy Rate

研究概览

简要总结

The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

详细描述

Polycystic ovary syndrome (PCOS) affects 5 to 10% of women of childbearing age and is the most common cause of anovulatory infertility. Common clinical manifestations include menstrual irregularities and signs of androgen excess such as hirsutism, acne, and alopecia. Metformin, a biguanide, is the most widely used drug for the treatment of type 2 diabetes worldwide. Its primary action is to inhibit hepatic glucose production, but it also increases the sensitivity of peripheral tissues to insulin. The increase in insulin sensitivity, which contributes to the efficacy of metformin in the treatment of diabetes, has also been shown in non diabetic women with the polycystic ovary syndrome.In women with PCOS, long-term treatment with metformin may increase ovulation, improve menstrual cyclicity, and reduce serum androgen levels; the use of metformin may also improve hirsutism. If published data on the effects of metformin in the prevention of diabetes can be extrapolated to women with the PCOS, then the drug may actually retard progression to glucose intolerance in affected women, as reported in a small, retrospective study. Ultrasonic vibrations spread in the form of a wave in medium such as a liquid or a solid. When the particles of an elastic medium are under ultrasonic vibration, they act continuously in only one direction. The lipolytic range of ultrasounds is 30-70 Kilohertz (KHz), and the best effects are obtained in a range between30-35 KHz. The depth of the treatment in the tissues is generally2-3 cm, to avoid muscles involvement. Biological effects of ultrasounds on adipocytes are: micro-mechanical, thermal, micro-streaming and cavitation. Cavitation ultrasound means that ultrasounds produce an alternation of decompression and compression waves in a fluid media which progressively increase the tension of the adipocyte until it implodes and frees the emulsified fat. The aim of the current work was to compare the efficacy of cavitation ultrasound, metformin or combination of both in obese women with polycystic ovary syndrome (PCOS) regarding clinical pregnancy rate, ovulation rate, insulin resistance, serum testosterone level, lipid profile.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Obese infertile polycystic ovarian syndrome (PCOS) women

排除标准

  • Women 40 years or older
  • Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months
  • Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy

研究组 & 干预措施

Cavitation US

Experimental

Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months

干预措施: Cavitation US (Device)

Metformin

Experimental

Metformin oral tablets 500 mg were given three times daily

干预措施: Metformin (Drug)

Cavitation US + metformin

Experimental

Combination of both Cavitation US + Metformin

干预措施: Cavitation US + Metformin (Other)

结局指标

主要结局

Clinical Pregnancy Rate

时间窗: 9 months

次要结局

  • Change in Serum Free Testosterone Level(Baseline and 3 months)
  • Change in Lipid Profile(Baseline and 3 months)
  • Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.(3 months)
  • Change in Insulin Resistance(Baseline and 3 months)

研究者

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

Mohamed Ellaithy

Lecturer

Ain Shams University

研究点 (1)

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