Cavitation Ultrasound in Treatment of Patients With PCOS

• ClinicalTrials.gov Identifier: NCT01622257
• Recruitment Status: Completed
• First Posted: June 19, 2012
• Results First Posted: February 7, 2013
• Last Update Posted: April 7, 2017
• Sponsor: Ain Shams University
• Information provided by (Responsible Party): Mohamed Ellaithy, Ain Shams University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
PCOS	Device: Cavitation US; Drug: Metformin; Other: Cavitation US + Metformin	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 198 participants
• Allocation: Randomized
• Intervention Model: Factorial Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Cavitation Ultrasound, Metformin or the Combination of Both in Obese Women With Polycystic Ovary Syndrome
• Study Start Date: June 2011
• Actual Primary Completion Date: January 2012
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
Experimental: Cavitation US; Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months	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).; Other Name: Cavi SMART
Experimental: Metformin; Metformin oral tablets 500 mg were given three times daily	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 Name: Glucophage, Bristol-Myers Squibb, New York, USA
Experimental: Cavitation US + metformin; Combination of both Cavitation US + Metformin	Other: Cavitation US + Metformin; Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months; Other Name: Glucophage + Cavi SMART

Outcome Measures

Primary Outcome Measures :

1. Clinical Pregnancy Rate [ Time Frame: 9 months ]

Secondary Outcome Measures :

1. Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay. [ Time Frame: 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.

2. Change in Insulin Resistance [ Time Frame: Baseline and 3 months ]
   Change in Fasting insulin concentration
3. Change in Serum Free Testosterone Level [ Time Frame: Baseline and 3 months ]
   Change in serum free testosterone levels
4. Change in Lipid Profile [ Time Frame: Baseline and 3 months ]
   Change in LDL levels was taken as the indicator of change in lipid profile

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Egypt

Ain shams university

Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

• Study Director: Mostafa I. Ibrahem, M.D.; Ain Shams University
• Study Chair: Mohamed I. Ellaithy, MD; Lecturer Obstetics & Gynecology Ain shams university faculty of medicine
• Principal Investigator: Ahmed K. Makled, MD; Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine

More Information

• Responsible Party: Mohamed Ellaithy, Lecturer, Ain Shams University
• ClinicalTrials.gov Identifier: NCT01622257
• Other Study ID Numbers: ASU6-2011
• First Posted: June 19, 2012
• Results First Posted: February 7, 2013
• Last Update Posted: April 7, 2017
• Last Verified: March 2017

Additional relevant MeSH terms:

Metformin; Hypoglycemic Agents; Physiological Effects of Drugs