Cavitation Ultrasound in Treatment of Patients With PCOS

NCT ID: NCT01622257

Last Updated: 2017-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 198 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-06-30
• Study Completion Date: 2012-06-30

Brief 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.

Conditions

PCOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cavitation US

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

Group Type: EXPERIMENTAL

Cavitation US

Intervention Type: DEVICE

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

Metformin oral tablets 500 mg were given three times daily

Group Type: EXPERIMENTAL

Metformin

Intervention Type: DRUG

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.

Cavitation US + metformin

Combination of both Cavitation US + Metformin

Group Type: EXPERIMENTAL

Cavitation US + Metformin

Intervention Type: OTHER

Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months

Interventions

Cavitation US

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).

Intervention Type: DEVICE

Metformin

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.

Intervention Type: DRUG

Cavitation US + Metformin

Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months

Intervention Type: OTHER

Other Intervention Names

Cavi SMART; Glucophage, Bristol-Myers Squibb, New York, USA; Glucophage + Cavi SMART

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Ellaithy

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mostafa I. Ibrahem, M.D.

Role: STUDY_DIRECTOR

Ain Shams University

Mohamed I. Ellaithy, MD

Role: STUDY_CHAIR

Lecturer Obstetics & Gynecology Ain shams university faculty of medicine

Ahmed K. Makled, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine

Locations

Ain shams university

Cairo, , Egypt

Countries

Egypt

Other Identifiers

ASU6-2011

Identifier Type: -

Identifier Source: org_study_id