Cavitation Ultrasound in Treatment of Patients With PCOS

PCOS Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01622257
• Other study ID #: ASU6-2011
• Status: Completed
• Phase: Phase 2
• First received: June 18, 2012
• Last updated: December 26, 2012
• Start date: June 2011
• Est. completion date: June 2012

Study information

• Verified date: December 2012
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• PCOS

Intervention

Device:
• 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).

Drug:
• 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.

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

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical Pregnancy Rate		9 months	No
Secondary	Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.	The Number of participants who had evidence of successful ovulation during the 3 months. Ovulation was diagnosed based on ultrasonographic folliculometry and/or luteal serum progesterone assay.Every month, folliculometry was done to count the number of antral follicles (AFC), follow follicular growth, measure dominant follicle diameter and detect occurrence of ovulation. a mid-luteal serum progesterone assay was done to confirm ovulation.; Ultrasound was performed serially till reaching preovulatory follicle(s of around 20 mm in diameter that then rupture to show a collapsed follicle in the same location with internal echoes consistent with its transformation to a corpus luteum. Progesterone assay was done using immulite 2000 apparatus chemiluminescent immunometric assay. Mid-luteal phase progesterone above 6 ng/mL was considered indicative of normal corpus. luteum function.	3 months	No
Secondary	Change in Insulin Resistance	Change in Fasting insulin concentration	Baseline and 3 months	No
Secondary	Change in Serum Free Testosterone Level	Change in serum free testosterone levels	Baseline and 3 months	No
Secondary	Change in Lipid Profile	Change in LDL levels was taken as the indicator of change in lipid profile	Baseline and 3 months	No