Cavitation Ultrasound in Treatment of Patients With PCOS

Phase 2

Completed

• Conditions: PCOS
• Interventions: Device: Cavitation US; Other: Cavitation US + Metformin; Drug: Metformin

• Registration Number: NCT01622257
• Lead Sponsor: Ain Shams University

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.

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2012-01
• Study Completion: 2012-06
• Study First Submitted: 2012-06-18
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Results First Submitted: 2012-10-14
• Results First Submitted QC: 2012-12-26
• Results First Posted: 2013-02-07
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-04-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 198

Inclusion Criteria

• Obese infertile polycystic ovarian syndrome (PCOS) women

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Cavitation US	Cavitation US	Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
Cavitation US + metformin	Cavitation US + Metformin	Combination of both Cavitation US + Metformin
Metformin	Metformin	Metformin oral tablets 500 mg were given three times daily

Primary Outcome Measures

Name	Time	Method
Clinical Pregnancy Rate	9 months

Secondary Outcome Measures

Name	Time	Method
Change in Lipid Profile	Baseline and 3 months	Change in LDL levels was taken as the indicator of change in lipid profile
Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.	3 months	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.
Change in Insulin Resistance	Baseline and 3 months	Change in Fasting insulin concentration
Change in Serum Free Testosterone Level	Baseline and 3 months	Change in serum free testosterone levels

Trial Locations

Locations (1)

Ain shams university; 🇪🇬 Cairo, Egypt