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

Phase 2
18 Years
40 Years
Not Enrolling

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Trial Information

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

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.

Inclusion Criteria:

- Obese infertile polycystic ovarian syndrome (PCOS) women

Exclusion Criteria:

- 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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Clinical Pregnancy Rate

Outcome Time Frame:

9 months

Safety Issue:


Principal Investigator

Mostafa I. Ibrahem, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Ain Shams University


Egypt: Institutional Review Board

Study ID:




Start Date:

June 2011

Completion Date:

June 2012

Related Keywords:

  • PCOS
  • Polycystic Ovary Syndrome