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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cavitation US | Experimental | Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months |
|
| Metformin | Experimental | Metformin oral tablets 500 mg were given three times daily |
|
| Cavitation US + metformin | Experimental | Combination of both Cavitation US + Metformin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cavitation US | Device | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa I. Ibrahem, M.D. | Ain Shams University | Study Director |
| Mohamed I. Ellaithy, MD | Lecturer Obstetics & Gynecology Ain shams university faculty of medicine | Study Chair |
| Ahmed K. Makled, MD | Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university | Cairo | Egypt |
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252 women were assessed for eligibility 54 women were excluded
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| ID | Title | Description |
|---|---|---|
| FG000 | Cavitation US | Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months |
| FG001 | Metformin | Metformin oral tablets 500 mg were given three times daily for 3 months |
| FG002 | Cavitation US + Metformin | Combination of both Cavitation US + Metformin |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cavitation US | Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months |
| BG001 | Metformin | Metformin oral tablets 500 mg were given three times daily for 3 months |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Clinical Pregnancy Rate | Posted | Number | participants | 9 months |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cavitation US | Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastrointestinal upset | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Moustafa Ibrahim | Assistant professor of Obstetrics & Gynecology, Ain-shams faculty of medicine | 00201001955996 | mi_monem@yahoo.com |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
|
| Metformin | Drug | 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. |
|
|
| Cavitation US + Metformin | Other | Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months |
|
|
| 3 months |
| Change in Insulin Resistance | Change in Fasting insulin concentration | Baseline and 3 months |
| Change in Serum Free Testosterone Level | Change in serum free testosterone levels | Baseline and 3 months |
| Change in Lipid Profile | Change in LDL levels was taken as the indicator of change in lipid profile | Baseline and 3 months |
| BG002 | Cavitation US + Metformin | Combination of both Cavitation US + Metformin |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Duration of infertility | Mean | Standard Deviation | Years |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Androgenic alopecia | Number | Participants |
|
| Acne | Number | Participants |
|
| Seborrheic dermatitis | Number | Participants |
|
| Menstrual pattern | Number | Participants |
|
| Systolic blood pressure | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Diastolic blood pressure | Mean | Standard Deviation | millimeters of mercury (mmHg) |
|
| Serum Follicle-stimulating Hormone (FSH) | Mean | Standard Deviation | mIU/ml |
|
| Luteinizing Hormone (LH) | Mean | Standard Deviation | mIU/ml |
|
| LH/FSH ratio | Mean | Standard Deviation | Ratio |
|
| Total testosterone | Mean | Standard Deviation | ng/ml |
|
| Free testosterone | Mean | Standard Deviation | pg/ml |
|
| Fasting insulin | Mean | Standard Deviation | µIU/ml |
|
| Fasting glucose | Mean | Standard Deviation | mg/dl |
|
| Fasting Glucose/Insulin Ratio (GIR) | Mean | Standard Deviation | mg/mIU |
|
| Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)= Fasting insulin x Fasting glucose / 22.5 | Mean | Standard Deviation | HOMA score |
|
| Quantitative Insulin sensitivity Check Index (QUICKI) | The quantitative insulin sensitivity check index (QUICKI) is derived using the inverse of the sum of the logarithms of the fasting insulin and fasting glucose: 1 / [(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)] µU/mL, microunits/milliliter; mg/dL, milligrams/deciliter. | Mean | Standard Deviation | Index |
|
| Total cholesterol | Mean | Standard Deviation | mg/dl |
|
| Low-density lipoprotein (LDL) | Mean | Standard Deviation | mg/dl |
|
| High-density lipoprotein (HDL) | Mean | Standard Deviation | mg/dl |
|
| Triglycerides (TGs) | Mean | Standard Deviation | mg/dl |
|
| Waist to Hip Ratio (WHR) | Mean | Standard Deviation | Ratio |
|
| Total body fat percent | Mean | Standard Deviation | Percentage |
|
| Body fat mass | Mean | Standard Deviation | Kilograms (kg) |
|
| Fat free mass | Mean | Standard Deviation | Kilograms (kg) |
|
| Abdominal fat mass | Mean | Standard Deviation | Kilograms (kg) |
|
| Emotion mean score | The Emotions score consists of 8 items:
For each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment. A 2-week time frame was chosen for patients to describe their function. PCOSQ Emotions mean score = the average of the 8 items (Range=1-7) (PCOSQ, The Polycystic Ovary Syndrome Questionnaire) | Mean | Standard Deviation | PCOSQ Emotion Score |
|
| Body hair mean score | The Body Hair score consists of 5 items:
For each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment. A 2-week time frame was chosen for patients to describe their function. PCOSQ Body hair mean score = the average of the 5 items (Range=1-7) (PCOSQ, The Polycystic Ovary Syndrome Questionnaire) | Mean | Standard Deviation | PCOSQ Body hair Score |
|
| Weight mean score | The Weight score consists of 5 items:
For each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment. A 2-week time frame was chosen for patients to describe their function. PCOSQ Weight mean score = the average of the 5 items (Range=1-7) (PCOSQ, The Polycystic Ovary Syndrome Questionnaire) | Mean | Standard Deviation | PCOSQ Weight Score |
|
| Menstrual problems mean score | The Menstrual problems score consists of 4 items:
For each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment. A 2-week time frame was chosen for patients to describe their function. PCOSQ Menstrual problems mean score = the average of the 4 items (Range=1-7) (PCOSQ, The Polycystic Ovary Syndrome Questionnaire) | Mean | Standard Deviation | PCOSQ Menstrual problems Score |
|
| Infertility mean score | The Infertility score consists of 4 items:
For each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment. A 2-week time frame was chosen for patients to describe their function. PCOSQ Infertility mean score = the average of the 4 items (Range=1-7) (PCOSQ, The Polycystic Ovary Syndrome Questionnaire) | Mean | Standard Deviation | PCOSQ Infertility Score |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Number | participants | 3 months |
|
|
|
| Secondary | Change in Insulin Resistance | Change in Fasting insulin concentration | Posted | Mean | 95% Confidence Interval | uIU/ml | Baseline and 3 months |
|
|
|
| Secondary | Change in Serum Free Testosterone Level | Change in serum free testosterone levels | Posted | Mean | 95% Confidence Interval | pg/ml | Baseline and 3 months |
|
|
|
| Secondary | Change in Lipid Profile | Change in LDL levels was taken as the indicator of change in lipid profile | Posted | Mean | 95% Confidence Interval | mg/dl | Baseline and 3 months |
|
|
|
| 0 |
| 66 |
| 9 |
| 66 |
| EG001 | Metformin | Metformin oral tablets 500 mg were given three times daily for 3 months | 0 | 66 | 15 | 66 |
| EG002 | Cavitation US + Metformin | Combination of both Cavitation US + Metformin | 0 | 66 | 19 | 66 |
| Generalized malaise | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Localized reaction | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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