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Cavitation Ultrasound in Treatment of Patients With PCOS

NCT01622257 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 198

Last updated 2017-04-07

Study results available
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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.

Conditions

  • PCOS

Interventions

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).

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

Cavitation US + Metformin

Combination of both Cavitation US + Metformin. the treatment duration lasts 3 months

Sponsors & Collaborators

  • Ain Shams University

    lead OTHER

Principal Investigators

  • Mostafa I. Ibrahem, M.D. · Ain Shams University

  • Mohamed I. Ellaithy, MD · Lecturer Obstetics & Gynecology Ain shams university faculty of medicine

  • Ahmed K. Makled, MD · Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-06-30
Primary Completion
2012-01-31
Completion
2012-06-30

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01622257 on ClinicalTrials.gov