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Cavitation Ultrasound in Treatment of Patients With PCOS

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT01622257
Collaborator
(none)
198
Enrollment
1
Location
3
Arms
12
Duration (Months)
16.5
Patients Per Site Per Month

Study Details

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
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
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 :
Jun 1, 2011
Actual Primary Completion Date :
Jan 1, 2012
Actual Study Completion Date :
Jun 1, 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 Names:
  • 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 Names:
  • 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 Names:
  • Glucophage + Cavi SMART

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical Pregnancy Rate [9 months]

    Secondary Outcome Measures

    1. 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.

    2. Change in Insulin Resistance [Baseline and 3 months]

      Change in Fasting insulin concentration

    3. Change in Serum Free Testosterone Level [Baseline and 3 months]

      Change in serum free testosterone levels

    4. Change in Lipid Profile [Baseline and 3 months]

      Change in LDL levels was taken as the indicator of change in lipid profile

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mohamed Ellaithy, Lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT01622257
    Other Study ID Numbers:
    • ASU6-2011
    First Posted:
    Jun 19, 2012
    Last Update Posted:
    Apr 7, 2017
    Last Verified:
    Mar 1, 2017
    Additional relevant MeSH terms:
    Metformin

    Study Results

    Participant Flow

    Recruitment Details 252 women were assessed for eligibility 54 women were excluded Not meeting inclusion criteria (n=38) Declined to participate (n=9) Other reasons (n=7)
    Pre-assignment Detail
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Period Title: Overall Study
    STARTED 66 66 66
    COMPLETED 66 66 66
    NOT COMPLETED 0 0 0

    Baseline Characteristics

    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin Total
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin Total of all reporting groups
    Overall Participants 66 66 66 198
    Age (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    25.7
    (4.5)
    26.1
    (4.1)
    26.3
    (5.2)
    26
    (4.7)
    Sex: Female, Male (Count of Participants)
    Female
    66
    100%
    66
    100%
    66
    100%
    198
    100%
    Male
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Region of Enrollment (Number) [Number]
    Egypt
    66
    100%
    66
    100%
    66
    100%
    198
    100%
    Duration of infertility (Years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Years]
    3.3
    (1.5)
    3.4
    (1.3)
    3.2
    (1.3)
    3.3
    (1.4)
    Body Mass Index (kg/m^2) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [kg/m^2]
    37.9
    (4.9)
    36.7
    (4.2)
    36.1
    (5.2)
    36.9
    (4.7)
    Androgenic alopecia (Number) [Number]
    Yes
    12
    18.2%
    9
    13.6%
    6
    9.1%
    27
    13.6%
    No
    54
    81.8%
    57
    86.4%
    60
    90.9%
    171
    86.4%
    Acne (Number) [Number]
    Yes
    18
    27.3%
    23
    34.8%
    26
    39.4%
    67
    33.8%
    No
    48
    72.7%
    43
    65.2%
    40
    60.6%
    131
    66.2%
    Seborrheic dermatitis (Number) [Number]
    Yes
    26
    39.4%
    34
    51.5%
    39
    59.1%
    99
    50%
    No
    40
    60.6%
    32
    48.5%
    27
    40.9%
    99
    50%
    Menstrual pattern (Number) [Number]
    Amenorrhea
    43
    65.2%
    47
    71.2%
    51
    77.3%
    141
    71.2%
    Oligomenorrhea
    23
    34.8%
    19
    28.8%
    15
    22.7%
    57
    28.8%
    Systolic blood pressure (millimeters of mercury (mmHg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeters of mercury (mmHg)]
    122.4
    (10.1)
    121.9
    (12.4)
    121.8
    (12.3)
    122
    (11.6)
    Diastolic blood pressure (millimeters of mercury (mmHg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [millimeters of mercury (mmHg)]
    80.5
    (8.2)
    81.6
    (7.1)
    82.9
    (7.8)
    81.7
    (7.6)
    Serum Follicle-stimulating Hormone (FSH) (mIU/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mIU/ml]
    6.1
    (1.9)
    5.8
    (2.2)
    6.6
    (2.3)
    6.2
    (2.1)
    Luteinizing Hormone (LH) (mIU/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mIU/ml]
    10.9
    (1.1)
    10.7
    (1.1)
    11.1
    (1.8)
    10.9
    (1.3)
    LH/FSH ratio (Ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Ratio]
    1.79
    (0.7)
    1.85
    (0.6)
    1.68
    (0.6)
    1.77
    (0.6)
    Total testosterone (ng/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [ng/ml]
    0.84
    (0.05)
    0.83
    (0.04)
    0.83
    (0.04)
    0.83
    (0.04)
    Free testosterone (pg/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [pg/ml]
    3.9
    (2.07)
    3.8
    (1.32)
    3.7
    (1.72)
    3.8
    (1.71)
    Fasting insulin (µIU/ml) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [µIU/ml]
    12.9
    (6.4)
    12.5
    (5.3)
    11.8
    (4.1)
    12.4
    (5.1)
    Fasting glucose (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    83.1
    (21.4)
    79.4
    (22.7)
    77.8
    (22.1)
    80.1
    (22.3)
    Fasting Glucose/Insulin Ratio (GIR) (mg/mIU) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/mIU]
    6.44
    (0.8)
    6.35
    (0.7)
    6.59
    (0.7)
    6.46
    (0.7)
    Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) (HOMA score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [HOMA score]
    2.65
    (1.01)
    2.45
    (1.06)
    2.27
    (0.99)
    2.46
    (1.01)
    Quantitative Insulin sensitivity Check Index (QUICKI) (Index) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Index]
    0.33
    (0.03)
    0.33
    (0.04)
    0.34
    (0.04)
    0.33
    (0.04)
    Total cholesterol (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    282.3
    (32)
    273.4
    (29.2)
    276.8
    (30.5)
    277.2
    (30.7)
    Low-density lipoprotein (LDL) (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    129.7
    (19.3)
    127.1
    (20.4)
    122.6
    (19.1)
    126.5
    (19.6)
    High-density lipoprotein (HDL) (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    80.9
    (11.2)
    77.8
    (9.9)
    82.1
    (10.8)
    80.4
    (10.6)
    Triglycerides (TGs) (mg/dl) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [mg/dl]
    204.9
    (28.1)
    199.6
    (22.4)
    208.4
    (26.8)
    204.3
    (25.7)
    Waist to Hip Ratio (WHR) (Ratio) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Ratio]
    0.88
    (0.7)
    0.89
    (0.7)
    0.91
    (0.8)
    0.89
    (0.7)
    Total body fat percent (Percentage) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Percentage]
    43.2
    (5.6)
    44.9
    (6.2)
    45.6
    (5.7)
    44.6
    (5.8)
    Body fat mass (Kilograms (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kilograms (kg)]
    37.7
    (10.4)
    39.8
    (11.2)
    41.1
    (10.1)
    39.5
    (10.5)
    Fat free mass (Kilograms (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kilograms (kg)]
    50.8
    (9.5)
    51.2
    (9.1)
    51.2
    (10.2)
    51.1
    (9.6)
    Abdominal fat mass (Kilograms (kg)) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [Kilograms (kg)]
    6.8
    (2.8)
    6.9
    (3.2)
    7.1
    (2.2)
    6.9
    (2.6)
    Emotion mean score (PCOSQ Emotion Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [PCOSQ Emotion Score]
    4.3
    (1.4)
    4.9
    (1.6)
    4.7
    (1.7)
    4.6
    (1.6)
    Body hair mean score (PCOSQ Body hair Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [PCOSQ Body hair Score]
    3.4
    (1.7)
    3.3
    (1.9)
    3.7
    (1.6)
    3.5
    (1.7)
    Weight mean score (PCOSQ Weight Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [PCOSQ Weight Score]
    2.6
    (1.4)
    2.4
    (1.3)
    2.1
    (1.5)
    2.4
    (1.4)
    Menstrual problems mean score (PCOSQ Menstrual problems Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [PCOSQ Menstrual problems Score]
    3.6
    (1.1)
    3.7
    (1.1)
    3.9
    (1.1)
    3.7
    (1.1)
    Infertility mean score (PCOSQ Infertility Score) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [PCOSQ Infertility Score]
    3.7
    (1.02)
    3.6
    (0.9)
    3.4
    (1.1)
    3.6
    (1)

    Outcome Measures

    1. Primary Outcome
    Title Clinical Pregnancy Rate
    Description
    Time Frame 9 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Measure Participants 66 66 66
    Number [participants]
    12
    18.2%
    5
    7.6%
    16
    24.2%
    2. Secondary Outcome
    Title Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.
    Description 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.
    Time Frame 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Measure Participants 66 66 66
    Number [participants]
    39
    59.1%
    16
    24.2%
    45
    68.2%
    3. Secondary Outcome
    Title Change in Insulin Resistance
    Description Change in Fasting insulin concentration
    Time Frame Baseline and 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Measure Participants 66 66 66
    Mean (95% Confidence Interval) [uIU/ml]
    -2.4
    -1.1
    -3.4
    4. Secondary Outcome
    Title Change in Serum Free Testosterone Level
    Description Change in serum free testosterone levels
    Time Frame Baseline and 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Measure Participants 66 66 66
    Mean (95% Confidence Interval) [pg/ml]
    -0.4
    -0.2
    -0.6
    5. Secondary Outcome
    Title Change in Lipid Profile
    Description Change in LDL levels was taken as the indicator of change in lipid profile
    Time Frame Baseline and 3 months

    Outcome Measure Data

    Analysis Population Description
    [Not Specified]
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    Measure Participants 66 66 66
    Mean (95% Confidence Interval) [mg/dl]
    -10.2
    -8.9
    -20.9

    Adverse Events

    Time Frame 3 months
    Adverse Event Reporting Description
    Arm/Group Title Cavitation US Metformin Cavitation US + Metformin
    Arm/Group Description Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months Metformin oral tablets 500 mg were given three times daily for 3 months Combination of both Cavitation US + Metformin
    All Cause Mortality
    Cavitation US Metformin Cavitation US + Metformin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total / (NaN) / (NaN) / (NaN)
    Serious Adverse Events
    Cavitation US Metformin Cavitation US + Metformin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/66 (0%) 0/66 (0%) 0/66 (0%)
    Other (Not Including Serious) Adverse Events
    Cavitation US Metformin Cavitation US + Metformin
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 9/66 (13.6%) 15/66 (22.7%) 19/66 (28.8%)
    Gastrointestinal disorders
    Gastrointestinal upset 0/66 (0%) 0 11/66 (16.7%) 34 9/66 (13.6%) 31
    Musculoskeletal and connective tissue disorders
    Generalized malaise 0/66 (0%) 0 4/66 (6.1%) 19 3/66 (4.5%) 17
    Skin and subcutaneous tissue disorders
    Localized reaction 9/66 (13.6%) 19 0/66 (0%) 0 7/66 (10.6%) 23

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    All Principal Investigators ARE employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/Title Dr. Moustafa Ibrahim
    Organization Assistant professor of Obstetrics & Gynecology, Ain-shams faculty of medicine
    Phone 00201001955996
    Email mi_monem@yahoo.com
    Responsible Party:
    Mohamed Ellaithy, Lecturer, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT01622257
    Other Study ID Numbers:
    • ASU6-2011
    First Posted:
    Jun 19, 2012
    Last Update Posted:
    Apr 7, 2017
    Last Verified:
    Mar 1, 2017