Cavitation Ultrasound in Treatment of Patients With PCOS
Condition: PCOS
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Cavitation US; Metformin; Cavitation US + Metformin
Intervention type(s): Device; Drug; Other
Intervention description(s): The areas with localized fat are treated 2 times per week for 3 months using Aesthetic cavitation via ultrasonic cavitation machine (Cavi SMART, South Korea, supplied with one piece cavitation probe of 40 KHz, 3-6 watt(W)/cm^2 adjustable, 60W with 20cm^2 active surface).; Metformin hydrochloride (Glucophage 500 mg/tablet, Bristol-Myers Squibb, New York, USA). Medication is initiated in a step-up fashion every 5 days, from one tablet per day to three. This dose is maintained as tolerated throughout the 3 months of the study.; Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months
Other intervention name(s): Cavi SMART; Glucophage, Bristol-Myers Squibb, New York, USA; Glucophage + Cavi SMART
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment