Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2025-12-29 @ 2:30 AM
Study NCT ID:
NCT01622257
Status:
COMPLETED
Last Update Posted:
2017-04-07
First Post:
2012-06-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Cavitation Ultrasound in Treatment of Patients With PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mi_monem@yahoo.com', 'phone': '00201001955996', 'title': 'Dr. Moustafa Ibrahim', 'organization': 'Assistant professor of Obstetrics & Gynecology, Ain-shams faculty of medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 months', 'eventGroups': [{'id': 'EG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months', 'otherNumAtRisk': 66, 'otherNumAffected': 9, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months', 'otherNumAtRisk': 66, 'otherNumAffected': 15, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin', 'otherNumAtRisk': 66, 'otherNumAffected': 19, 'seriousNumAtRisk': 66, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Gastrointestinal upset', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 34, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 31, 'numAffected': 9}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Generalized malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 19, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 17, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Localized reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 19, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 66, 'numEvents': 23, 'numAffected': 7}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '1.52'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Pregnancy Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'OG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '9 months', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'OG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', '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.\n\nUltrasound 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.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Insulin Resistance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'OG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.4', 'groupId': 'OG000', 'lowerLimit': '-2.61', 'upperLimit': '-2.1'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-1.21', 'upperLimit': '-0.9'}, {'value': '-3.4', 'groupId': 'OG002', 'lowerLimit': '-3.74', 'upperLimit': '-3.0'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in Fasting insulin concentration', 'unitOfMeasure': 'uIU/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Serum Free Testosterone Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'OG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.4', 'groupId': 'OG000', 'lowerLimit': '-0.44', 'upperLimit': '-0.36'}, {'value': '-0.2', 'groupId': 'OG001', 'lowerLimit': '-0.22', 'upperLimit': '-0.18'}, {'value': '-0.6', 'groupId': 'OG002', 'lowerLimit': '-0.65', 'upperLimit': '-0.55'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in serum free testosterone levels', 'unitOfMeasure': 'pg/ml', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Lipid Profile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'OG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'OG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.2', 'groupId': 'OG000', 'lowerLimit': '-11.08', 'upperLimit': '-9.32'}, {'value': '-8.9', 'groupId': 'OG001', 'lowerLimit': '-9.78', 'upperLimit': '-8.02'}, {'value': '-20.9', 'groupId': 'OG002', 'lowerLimit': '-22.9', 'upperLimit': '-18.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in LDL levels was taken as the indicator of change in lipid profile', 'unitOfMeasure': 'mg/dl', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'FG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'FG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '66'}, {'groupId': 'FG002', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': '252 women were assessed for eligibility 54 women were excluded\n\n* Not meeting inclusion criteria (n=38)\n* Declined to participate (n=9)\n* Other reasons (n=7)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months'}, {'id': 'BG001', 'title': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily for 3 months'}, {'id': 'BG002', 'title': 'Cavitation US + Metformin', 'description': 'Combination of both Cavitation US + Metformin'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '4.5', 'groupId': 'BG000'}, {'value': '26.1', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '26.3', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '26', 'spread': '4.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Egypt', 'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}, {'value': '198', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Duration of infertility', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '3.4', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '3.2', 'spread': '1.3', 'groupId': 'BG002'}, {'value': '3.3', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '37.9', 'spread': '4.9', 'groupId': 'BG000'}, {'value': '36.7', 'spread': '4.2', 'groupId': 'BG001'}, {'value': '36.1', 'spread': '5.2', 'groupId': 'BG002'}, {'value': '36.9', 'spread': '4.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Androgenic alopecia', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '54', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '171', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Acne', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Seborrheic dermatitis', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '99', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Menstrual pattern', 'classes': [{'title': 'Amenorrhea', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '141', 'groupId': 'BG003'}]}]}, {'title': 'Oligomenorrhea', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '57', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '122.4', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '121.9', 'spread': '12.4', 'groupId': 'BG001'}, {'value': '121.8', 'spread': '12.3', 'groupId': 'BG002'}, {'value': '122', 'spread': '11.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '80.5', 'spread': '8.2', 'groupId': 'BG000'}, {'value': '81.6', 'spread': '7.1', 'groupId': 'BG001'}, {'value': '82.9', 'spread': '7.8', 'groupId': 'BG002'}, {'value': '81.7', 'spread': '7.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'millimeters of mercury (mmHg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Serum Follicle-stimulating Hormone (FSH)', 'classes': [{'categories': [{'measurements': [{'value': '6.1', 'spread': '1.9', 'groupId': 'BG000'}, {'value': '5.8', 'spread': '2.2', 'groupId': 'BG001'}, {'value': '6.6', 'spread': '2.3', 'groupId': 'BG002'}, {'value': '6.2', 'spread': '2.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Luteinizing Hormone (LH)', 'classes': [{'categories': [{'measurements': [{'value': '10.9', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '10.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '11.1', 'spread': '1.8', 'groupId': 'BG002'}, {'value': '10.9', 'spread': '1.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mIU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LH/FSH ratio', 'classes': [{'categories': [{'measurements': [{'value': '1.79', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '1.85', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '1.68', 'spread': '0.6', 'groupId': 'BG002'}, {'value': '1.77', 'spread': '0.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total testosterone', 'classes': [{'categories': [{'measurements': [{'value': '0.84', 'spread': '0.05', 'groupId': 'BG000'}, {'value': '0.83', 'spread': '0.04', 'groupId': 'BG001'}, {'value': '0.83', 'spread': '0.04', 'groupId': 'BG002'}, {'value': '0.83', 'spread': '0.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ng/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Free testosterone', 'classes': [{'categories': [{'measurements': [{'value': '3.9', 'spread': '2.07', 'groupId': 'BG000'}, {'value': '3.8', 'spread': '1.32', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '1.72', 'groupId': 'BG002'}, {'value': '3.8', 'spread': '1.71', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting insulin', 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '12.5', 'spread': '5.3', 'groupId': 'BG001'}, {'value': '11.8', 'spread': '4.1', 'groupId': 'BG002'}, {'value': '12.4', 'spread': '5.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'µIU/ml', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting glucose', 'classes': [{'categories': [{'measurements': [{'value': '83.1', 'spread': '21.4', 'groupId': 'BG000'}, {'value': '79.4', 'spread': '22.7', 'groupId': 'BG001'}, {'value': '77.8', 'spread': '22.1', 'groupId': 'BG002'}, {'value': '80.1', 'spread': '22.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fasting Glucose/Insulin Ratio (GIR)', 'classes': [{'categories': [{'measurements': [{'value': '6.44', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '6.35', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '6.59', 'spread': '0.7', 'groupId': 'BG002'}, {'value': '6.46', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/mIU', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)', 'classes': [{'categories': [{'measurements': [{'value': '2.65', 'spread': '1.01', 'groupId': 'BG000'}, {'value': '2.45', 'spread': '1.06', 'groupId': 'BG001'}, {'value': '2.27', 'spread': '0.99', 'groupId': 'BG002'}, {'value': '2.46', 'spread': '1.01', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)= Fasting insulin x Fasting glucose / 22.5', 'unitOfMeasure': 'HOMA score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Quantitative Insulin sensitivity Check Index (QUICKI)', 'classes': [{'categories': [{'measurements': [{'value': '0.33', 'spread': '0.03', 'groupId': 'BG000'}, {'value': '0.33', 'spread': '0.04', 'groupId': 'BG001'}, {'value': '0.34', 'spread': '0.04', 'groupId': 'BG002'}, {'value': '0.33', 'spread': '0.04', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': '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:\n\n1 / \\[(log(fasting insulin µU/mL) + log(fasting glucose mg/dL)\\]\n\nµU/mL, microunits/milliliter; mg/dL, milligrams/deciliter.', 'unitOfMeasure': 'Index', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '282.3', 'spread': '32', 'groupId': 'BG000'}, {'value': '273.4', 'spread': '29.2', 'groupId': 'BG001'}, {'value': '276.8', 'spread': '30.5', 'groupId': 'BG002'}, {'value': '277.2', 'spread': '30.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Low-density lipoprotein (LDL)', 'classes': [{'categories': [{'measurements': [{'value': '129.7', 'spread': '19.3', 'groupId': 'BG000'}, {'value': '127.1', 'spread': '20.4', 'groupId': 'BG001'}, {'value': '122.6', 'spread': '19.1', 'groupId': 'BG002'}, {'value': '126.5', 'spread': '19.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-density lipoprotein (HDL)', 'classes': [{'categories': [{'measurements': [{'value': '80.9', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '77.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '82.1', 'spread': '10.8', 'groupId': 'BG002'}, {'value': '80.4', 'spread': '10.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides (TGs)', 'classes': [{'categories': [{'measurements': [{'value': '204.9', 'spread': '28.1', 'groupId': 'BG000'}, {'value': '199.6', 'spread': '22.4', 'groupId': 'BG001'}, {'value': '208.4', 'spread': '26.8', 'groupId': 'BG002'}, {'value': '204.3', 'spread': '25.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Waist to Hip Ratio (WHR)', 'classes': [{'categories': [{'measurements': [{'value': '0.88', 'spread': '0.7', 'groupId': 'BG000'}, {'value': '0.89', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '0.91', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '0.89', 'spread': '0.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Ratio', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Total body fat percent', 'classes': [{'categories': [{'measurements': [{'value': '43.2', 'spread': '5.6', 'groupId': 'BG000'}, {'value': '44.9', 'spread': '6.2', 'groupId': 'BG001'}, {'value': '45.6', 'spread': '5.7', 'groupId': 'BG002'}, {'value': '44.6', 'spread': '5.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percentage', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body fat mass', 'classes': [{'categories': [{'measurements': [{'value': '37.7', 'spread': '10.4', 'groupId': 'BG000'}, {'value': '39.8', 'spread': '11.2', 'groupId': 'BG001'}, {'value': '41.1', 'spread': '10.1', 'groupId': 'BG002'}, {'value': '39.5', 'spread': '10.5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Fat free mass', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '9.5', 'groupId': 'BG000'}, {'value': '51.2', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '51.2', 'spread': '10.2', 'groupId': 'BG002'}, {'value': '51.1', 'spread': '9.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Abdominal fat mass', 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '2.8', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '3.2', 'groupId': 'BG001'}, {'value': '7.1', 'spread': '2.2', 'groupId': 'BG002'}, {'value': '6.9', 'spread': '2.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kilograms (kg)', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Emotion mean score', 'classes': [{'categories': [{'measurements': [{'value': '4.3', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '4.9', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '4.7', 'spread': '1.7', 'groupId': 'BG002'}, {'value': '4.6', 'spread': '1.6', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Emotions score consists of 8 items:\n\n* Depressed\n* Easily tired\n* Moody\n* Had low self-esteem\n* Fear of getting cancer\n* Worried\n* Being self-conscious\n* Late menstrual period\n\nFor each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment.\n\nA 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)', 'unitOfMeasure': 'PCOSQ Emotion Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body hair mean score', 'classes': [{'categories': [{'measurements': [{'value': '3.4', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '3.3', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '3.7', 'spread': '1.6', 'groupId': 'BG002'}, {'value': '3.5', 'spread': '1.7', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Body Hair score consists of 5 items:\n\n* Visible hair on chin\n* Visible hair on upper lip\n* Visible hair on face\n* Embarrassment about excessive body hair\n* Visible body hair\n\nFor each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment.\n\nA 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)', 'unitOfMeasure': 'PCOSQ Body hair Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight mean score', 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '2.4', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '2.1', 'spread': '1.5', 'groupId': 'BG002'}, {'value': '2.4', 'spread': '1.4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Weight score consists of 5 items:\n\n* Concerned about being overweight\n* Trouble dealing with your weight\n* Frustration in losing weight\n* Do not feel sexy because of weight\n* Difficulties staying at ideal weight\n\nFor each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment.\n\nA 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)', 'unitOfMeasure': 'PCOSQ Weight Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Menstrual problems mean score', 'classes': [{'categories': [{'measurements': [{'value': '3.6', 'spread': '1.1', 'groupId': 'BG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '3.9', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Menstrual problems score consists of 4 items:\n\n* Headaches\n* Irregular menstrual periods\n* Abdominal Bloating\n* Menstrual cramps\n\nFor each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment.\n\nA 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)', 'unitOfMeasure': 'PCOSQ Menstrual problems Score', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Infertility mean score', 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.02', 'groupId': 'BG000'}, {'value': '3.6', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '1.1', 'groupId': 'BG002'}, {'value': '3.6', 'spread': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'The Infertility score consists of 4 items:\n\n* Concerned with infertility problems\n* Fear of not having children\n* Feel lack of control over the situation\n* Sadness because of infertility problems\n\nFor each item there are seven rating options, 1 represents the greatest possible impairment, while 7 represents the least impairment.\n\nA 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)', 'unitOfMeasure': 'PCOSQ Infertility Score', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 198}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-09', 'studyFirstSubmitDate': '2012-06-18', 'resultsFirstSubmitDate': '2012-10-14', 'studyFirstSubmitQcDate': '2012-06-18', 'lastUpdatePostDateStruct': {'date': '2017-04-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2012-12-26', 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-02-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Pregnancy Rate', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.', 'timeFrame': '3 months', '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.\n\nUltrasound 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.'}, {'measure': 'Change in Insulin Resistance', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in Fasting insulin concentration'}, {'measure': 'Change in Serum Free Testosterone Level', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in serum free testosterone levels'}, {'measure': 'Change in Lipid Profile', 'timeFrame': 'Baseline and 3 months', 'description': 'Change in LDL levels was taken as the indicator of change in lipid profile'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['PCOS']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Obese infertile polycystic ovarian syndrome (PCOS) women\n\nExclusion Criteria:\n\n* Women 40 years or older\n* Women using fertility treatments, oral contraceptives or other confounding medications during the last 3 months\n* Smokers or with history of general diseases like cardiovascular, liver, kidney or respiratory disease, diabetes, uncontrolled hypertension, or malignancy'}, 'identificationModule': {'nctId': 'NCT01622257', 'briefTitle': 'Cavitation Ultrasound in Treatment of Patients With PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparison of Cavitation Ultrasound, Metformin or the Combination of Both in Obese Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'ASU6-2011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cavitation US', 'description': 'Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months', 'interventionNames': ['Device: Cavitation US']}, {'type': 'EXPERIMENTAL', 'label': 'Metformin', 'description': 'Metformin oral tablets 500 mg were given three times daily', 'interventionNames': ['Drug: Metformin']}, {'type': 'EXPERIMENTAL', 'label': 'Cavitation US + metformin', 'description': 'Combination of both Cavitation US + Metformin', 'interventionNames': ['Other: Cavitation US + Metformin']}], 'interventions': [{'name': 'Cavitation US', 'type': 'DEVICE', 'otherNames': ['Cavi SMART'], 'description': '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).', 'armGroupLabels': ['Cavitation US']}, {'name': 'Metformin', 'type': 'DRUG', 'otherNames': ['Glucophage, Bristol-Myers Squibb, New York, USA'], 'description': '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.', 'armGroupLabels': ['Metformin']}, {'name': 'Cavitation US + Metformin', 'type': 'OTHER', 'otherNames': ['Glucophage + Cavi SMART'], 'description': 'Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months', 'armGroupLabels': ['Cavitation US + metformin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain shams university', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mostafa I. Ibrahem, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University'}, {'name': 'Mohamed I. Ellaithy, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Lecturer Obstetics & Gynecology Ain shams university faculty of medicine'}, {'name': 'Ahmed K. Makled, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Mohamed Ellaithy', 'investigatorAffiliation': 'Ain Shams University'}}}}