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Cavitation Ultrasound in Treatment of Patients With PCOS

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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:
Information provided by (Responsible Party):
Mohamed Ellaithy, 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.

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.

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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

Resource links provided by the National Library of Medicine


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




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622257


Locations
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Egypt
Ain shams university
Cairo, Egypt
Sponsors and Collaborators
Ain Shams University
Investigators
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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

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Responsible Party: Mohamed Ellaithy, Lecturer, Ain Shams University
ClinicalTrials.gov Identifier: NCT01622257    
Other Study ID Numbers: ASU6-2011
First Posted: June 19, 2012    Key Record Dates
Results First Posted: February 7, 2013
Last Update Posted: April 7, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Metformin
Hypoglycemic Agents
Physiological Effects of Drugs