Trial Outcomes & Findings for Cavitation Ultrasound in Treatment of Patients With PCOS (NCT NCT01622257)
NCT ID: NCT01622257
Last Updated: 2017-04-07
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
198 participants
Primary outcome timeframe
9 months
Results posted on
2017-04-07
Participant Flow
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)
Participant milestones
| Measure |
Cavitation US
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
66
|
|
Overall Study
COMPLETED
|
66
|
66
|
66
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Cavitation Ultrasound in Treatment of Patients With PCOS
Baseline characteristics by cohort
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
Total
n=198 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
25.7 Years
STANDARD_DEVIATION 4.5 • n=5 Participants
|
26.1 Years
STANDARD_DEVIATION 4.1 • n=7 Participants
|
26.3 Years
STANDARD_DEVIATION 5.2 • n=5 Participants
|
26 Years
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
Egypt
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
198 Participants
n=4 Participants
|
|
Duration of infertility
|
3.3 Years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
3.4 Years
STANDARD_DEVIATION 1.3 • n=7 Participants
|
3.2 Years
STANDARD_DEVIATION 1.3 • n=5 Participants
|
3.3 Years
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Body Mass Index
|
37.9 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
36.7 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
36.1 kg/m^2
STANDARD_DEVIATION 5.2 • n=5 Participants
|
36.9 kg/m^2
STANDARD_DEVIATION 4.7 • n=4 Participants
|
|
Androgenic alopecia
Yes
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
27 Participants
n=4 Participants
|
|
Androgenic alopecia
No
|
54 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
171 Participants
n=4 Participants
|
|
Acne
Yes
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
67 Participants
n=4 Participants
|
|
Acne
No
|
48 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
131 Participants
n=4 Participants
|
|
Seborrheic dermatitis
Yes
|
26 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Seborrheic dermatitis
No
|
40 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
99 Participants
n=4 Participants
|
|
Menstrual pattern
Amenorrhea
|
43 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
|
Menstrual pattern
Oligomenorrhea
|
23 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
|
Systolic blood pressure
|
122.4 millimeters of mercury (mmHg)
STANDARD_DEVIATION 10.1 • n=5 Participants
|
121.9 millimeters of mercury (mmHg)
STANDARD_DEVIATION 12.4 • n=7 Participants
|
121.8 millimeters of mercury (mmHg)
STANDARD_DEVIATION 12.3 • n=5 Participants
|
122 millimeters of mercury (mmHg)
STANDARD_DEVIATION 11.6 • n=4 Participants
|
|
Diastolic blood pressure
|
80.5 millimeters of mercury (mmHg)
STANDARD_DEVIATION 8.2 • n=5 Participants
|
81.6 millimeters of mercury (mmHg)
STANDARD_DEVIATION 7.1 • n=7 Participants
|
82.9 millimeters of mercury (mmHg)
STANDARD_DEVIATION 7.8 • n=5 Participants
|
81.7 millimeters of mercury (mmHg)
STANDARD_DEVIATION 7.6 • n=4 Participants
|
|
Serum Follicle-stimulating Hormone (FSH)
|
6.1 mIU/ml
STANDARD_DEVIATION 1.9 • n=5 Participants
|
5.8 mIU/ml
STANDARD_DEVIATION 2.2 • n=7 Participants
|
6.6 mIU/ml
STANDARD_DEVIATION 2.3 • n=5 Participants
|
6.2 mIU/ml
STANDARD_DEVIATION 2.1 • n=4 Participants
|
|
Luteinizing Hormone (LH)
|
10.9 mIU/ml
STANDARD_DEVIATION 1.1 • n=5 Participants
|
10.7 mIU/ml
STANDARD_DEVIATION 1.1 • n=7 Participants
|
11.1 mIU/ml
STANDARD_DEVIATION 1.8 • n=5 Participants
|
10.9 mIU/ml
STANDARD_DEVIATION 1.3 • n=4 Participants
|
|
LH/FSH ratio
|
1.79 Ratio
STANDARD_DEVIATION 0.7 • n=5 Participants
|
1.85 Ratio
STANDARD_DEVIATION 0.6 • n=7 Participants
|
1.68 Ratio
STANDARD_DEVIATION 0.6 • n=5 Participants
|
1.77 Ratio
STANDARD_DEVIATION 0.6 • n=4 Participants
|
|
Total testosterone
|
0.84 ng/ml
STANDARD_DEVIATION 0.05 • n=5 Participants
|
0.83 ng/ml
STANDARD_DEVIATION 0.04 • n=7 Participants
|
0.83 ng/ml
STANDARD_DEVIATION 0.04 • n=5 Participants
|
0.83 ng/ml
STANDARD_DEVIATION 0.04 • n=4 Participants
|
|
Free testosterone
|
3.9 pg/ml
STANDARD_DEVIATION 2.07 • n=5 Participants
|
3.8 pg/ml
STANDARD_DEVIATION 1.32 • n=7 Participants
|
3.7 pg/ml
STANDARD_DEVIATION 1.72 • n=5 Participants
|
3.8 pg/ml
STANDARD_DEVIATION 1.71 • n=4 Participants
|
|
Fasting insulin
|
12.9 µIU/ml
STANDARD_DEVIATION 6.4 • n=5 Participants
|
12.5 µIU/ml
STANDARD_DEVIATION 5.3 • n=7 Participants
|
11.8 µIU/ml
STANDARD_DEVIATION 4.1 • n=5 Participants
|
12.4 µIU/ml
STANDARD_DEVIATION 5.1 • n=4 Participants
|
|
Fasting glucose
|
83.1 mg/dl
STANDARD_DEVIATION 21.4 • n=5 Participants
|
79.4 mg/dl
STANDARD_DEVIATION 22.7 • n=7 Participants
|
77.8 mg/dl
STANDARD_DEVIATION 22.1 • n=5 Participants
|
80.1 mg/dl
STANDARD_DEVIATION 22.3 • n=4 Participants
|
|
Fasting Glucose/Insulin Ratio (GIR)
|
6.44 mg/mIU
STANDARD_DEVIATION 0.8 • n=5 Participants
|
6.35 mg/mIU
STANDARD_DEVIATION 0.7 • n=7 Participants
|
6.59 mg/mIU
STANDARD_DEVIATION 0.7 • n=5 Participants
|
6.46 mg/mIU
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
|
2.65 HOMA score
STANDARD_DEVIATION 1.01 • n=5 Participants
|
2.45 HOMA score
STANDARD_DEVIATION 1.06 • n=7 Participants
|
2.27 HOMA score
STANDARD_DEVIATION 0.99 • n=5 Participants
|
2.46 HOMA score
STANDARD_DEVIATION 1.01 • n=4 Participants
|
|
Quantitative Insulin sensitivity Check Index (QUICKI)
|
0.33 Index
STANDARD_DEVIATION 0.03 • n=5 Participants
|
0.33 Index
STANDARD_DEVIATION 0.04 • n=7 Participants
|
0.34 Index
STANDARD_DEVIATION 0.04 • n=5 Participants
|
0.33 Index
STANDARD_DEVIATION 0.04 • n=4 Participants
|
|
Total cholesterol
|
282.3 mg/dl
STANDARD_DEVIATION 32 • n=5 Participants
|
273.4 mg/dl
STANDARD_DEVIATION 29.2 • n=7 Participants
|
276.8 mg/dl
STANDARD_DEVIATION 30.5 • n=5 Participants
|
277.2 mg/dl
STANDARD_DEVIATION 30.7 • n=4 Participants
|
|
Low-density lipoprotein (LDL)
|
129.7 mg/dl
STANDARD_DEVIATION 19.3 • n=5 Participants
|
127.1 mg/dl
STANDARD_DEVIATION 20.4 • n=7 Participants
|
122.6 mg/dl
STANDARD_DEVIATION 19.1 • n=5 Participants
|
126.5 mg/dl
STANDARD_DEVIATION 19.6 • n=4 Participants
|
|
High-density lipoprotein (HDL)
|
80.9 mg/dl
STANDARD_DEVIATION 11.2 • n=5 Participants
|
77.8 mg/dl
STANDARD_DEVIATION 9.9 • n=7 Participants
|
82.1 mg/dl
STANDARD_DEVIATION 10.8 • n=5 Participants
|
80.4 mg/dl
STANDARD_DEVIATION 10.6 • n=4 Participants
|
|
Triglycerides (TGs)
|
204.9 mg/dl
STANDARD_DEVIATION 28.1 • n=5 Participants
|
199.6 mg/dl
STANDARD_DEVIATION 22.4 • n=7 Participants
|
208.4 mg/dl
STANDARD_DEVIATION 26.8 • n=5 Participants
|
204.3 mg/dl
STANDARD_DEVIATION 25.7 • n=4 Participants
|
|
Waist to Hip Ratio (WHR)
|
0.88 Ratio
STANDARD_DEVIATION 0.7 • n=5 Participants
|
0.89 Ratio
STANDARD_DEVIATION 0.7 • n=7 Participants
|
0.91 Ratio
STANDARD_DEVIATION 0.8 • n=5 Participants
|
0.89 Ratio
STANDARD_DEVIATION 0.7 • n=4 Participants
|
|
Total body fat percent
|
43.2 Percentage
STANDARD_DEVIATION 5.6 • n=5 Participants
|
44.9 Percentage
STANDARD_DEVIATION 6.2 • n=7 Participants
|
45.6 Percentage
STANDARD_DEVIATION 5.7 • n=5 Participants
|
44.6 Percentage
STANDARD_DEVIATION 5.8 • n=4 Participants
|
|
Body fat mass
|
37.7 Kilograms (kg)
STANDARD_DEVIATION 10.4 • n=5 Participants
|
39.8 Kilograms (kg)
STANDARD_DEVIATION 11.2 • n=7 Participants
|
41.1 Kilograms (kg)
STANDARD_DEVIATION 10.1 • n=5 Participants
|
39.5 Kilograms (kg)
STANDARD_DEVIATION 10.5 • n=4 Participants
|
|
Fat free mass
|
50.8 Kilograms (kg)
STANDARD_DEVIATION 9.5 • n=5 Participants
|
51.2 Kilograms (kg)
STANDARD_DEVIATION 9.1 • n=7 Participants
|
51.2 Kilograms (kg)
STANDARD_DEVIATION 10.2 • n=5 Participants
|
51.1 Kilograms (kg)
STANDARD_DEVIATION 9.6 • n=4 Participants
|
|
Abdominal fat mass
|
6.8 Kilograms (kg)
STANDARD_DEVIATION 2.8 • n=5 Participants
|
6.9 Kilograms (kg)
STANDARD_DEVIATION 3.2 • n=7 Participants
|
7.1 Kilograms (kg)
STANDARD_DEVIATION 2.2 • n=5 Participants
|
6.9 Kilograms (kg)
STANDARD_DEVIATION 2.6 • n=4 Participants
|
|
Emotion mean score
|
4.3 PCOSQ Emotion Score
STANDARD_DEVIATION 1.4 • n=5 Participants
|
4.9 PCOSQ Emotion Score
STANDARD_DEVIATION 1.6 • n=7 Participants
|
4.7 PCOSQ Emotion Score
STANDARD_DEVIATION 1.7 • n=5 Participants
|
4.6 PCOSQ Emotion Score
STANDARD_DEVIATION 1.6 • n=4 Participants
|
|
Body hair mean score
|
3.4 PCOSQ Body hair Score
STANDARD_DEVIATION 1.7 • n=5 Participants
|
3.3 PCOSQ Body hair Score
STANDARD_DEVIATION 1.9 • n=7 Participants
|
3.7 PCOSQ Body hair Score
STANDARD_DEVIATION 1.6 • n=5 Participants
|
3.5 PCOSQ Body hair Score
STANDARD_DEVIATION 1.7 • n=4 Participants
|
|
Weight mean score
|
2.6 PCOSQ Weight Score
STANDARD_DEVIATION 1.4 • n=5 Participants
|
2.4 PCOSQ Weight Score
STANDARD_DEVIATION 1.3 • n=7 Participants
|
2.1 PCOSQ Weight Score
STANDARD_DEVIATION 1.5 • n=5 Participants
|
2.4 PCOSQ Weight Score
STANDARD_DEVIATION 1.4 • n=4 Participants
|
|
Menstrual problems mean score
|
3.6 PCOSQ Menstrual problems Score
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.7 PCOSQ Menstrual problems Score
STANDARD_DEVIATION 1.1 • n=7 Participants
|
3.9 PCOSQ Menstrual problems Score
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.7 PCOSQ Menstrual problems Score
STANDARD_DEVIATION 1.1 • n=4 Participants
|
|
Infertility mean score
|
3.7 PCOSQ Infertility Score
STANDARD_DEVIATION 1.02 • n=5 Participants
|
3.6 PCOSQ Infertility Score
STANDARD_DEVIATION 0.9 • n=7 Participants
|
3.4 PCOSQ Infertility Score
STANDARD_DEVIATION 1.1 • n=5 Participants
|
3.6 PCOSQ Infertility Score
STANDARD_DEVIATION 1 • n=4 Participants
|
PRIMARY outcome
Timeframe: 9 monthsOutcome measures
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Clinical Pregnancy Rate
|
12 participants
|
5 participants
|
16 participants
|
SECONDARY outcome
Timeframe: 3 monthsThe 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.
Outcome measures
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.
|
39 participants
|
16 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsChange in Fasting insulin concentration
Outcome measures
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Change in Insulin Resistance
|
-2.4 uIU/ml
Interval -2.61 to -2.1
|
-1.1 uIU/ml
Interval -1.21 to -0.9
|
-3.4 uIU/ml
Interval -3.74 to -3.0
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsChange in serum free testosterone levels
Outcome measures
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Change in Serum Free Testosterone Level
|
-0.4 pg/ml
Interval -0.44 to -0.36
|
-0.2 pg/ml
Interval -0.22 to -0.18
|
-0.6 pg/ml
Interval -0.65 to -0.55
|
SECONDARY outcome
Timeframe: Baseline and 3 monthsChange in LDL levels was taken as the indicator of change in lipid profile
Outcome measures
| Measure |
Cavitation US
n=66 Participants
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 Participants
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 Participants
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Change in Lipid Profile
|
-10.2 mg/dl
Interval -11.08 to -9.32
|
-8.9 mg/dl
Interval -9.78 to -8.02
|
-20.9 mg/dl
Interval -22.9 to -18.9
|
Adverse Events
Cavitation US
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Metformin
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Cavitation US + Metformin
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cavitation US
n=66 participants at risk
Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months
|
Metformin
n=66 participants at risk
Metformin oral tablets 500 mg were given three times daily for 3 months
|
Cavitation US + Metformin
n=66 participants at risk
Combination of both Cavitation US + Metformin
|
|---|---|---|---|
|
Gastrointestinal disorders
Gastrointestinal upset
|
0.00%
0/66 • 3 months
|
16.7%
11/66 • Number of events 34 • 3 months
|
13.6%
9/66 • Number of events 31 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Generalized malaise
|
0.00%
0/66 • 3 months
|
6.1%
4/66 • Number of events 19 • 3 months
|
4.5%
3/66 • Number of events 17 • 3 months
|
|
Skin and subcutaneous tissue disorders
Localized reaction
|
13.6%
9/66 • Number of events 19 • 3 months
|
0.00%
0/66 • 3 months
|
10.6%
7/66 • Number of events 23 • 3 months
|
Additional Information
Dr. Moustafa Ibrahim
Assistant professor of Obstetrics & Gynecology, Ain-shams faculty of medicine
Phone: 00201001955996
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place