Cavitation Ultrasound in Treatment of Patients With PCOS

NCT01622257 | Completed Phase 2 Results DMC

• 1 other identifier: ASU6-2011
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

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.

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

• Clinical Pregnancy Rate

  9 months

Secondary Outcomes (4)

• Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.

  3 months

• Change in Insulin Resistance

  Baseline and 3 months

• Change in Serum Free Testosterone Level

  Baseline and 3 months

• Change in Lipid Profile

  Baseline and 3 months

Study Arms (3)

Cavitation US

EXPERIMENTAL

Cavitation ultrasound was done using ultrasonic cavitation machine 2 times per week for 3 months

Device: Cavitation US

Metformin

EXPERIMENTAL

Metformin oral tablets 500 mg were given three times daily

Drug: Metformin

Cavitation US + metformin

EXPERIMENTAL

Combination of both Cavitation US + Metformin

Other: Cavitation US + Metformin

Interventions

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).

Also known as: Cavi SMART

Cavitation US

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.

Also known as: Glucophage, Bristol-Myers Squibb, New York, USA

Metformin

Cavitation US + Metformin OTHER

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

Also known as: Glucophage + Cavi SMART

Cavitation US + metformin

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Obese infertile polycystic ovarian syndrome (PCOS) women

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt

Location

MeSH Terms

Interventions

Metformin

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Results Point of Contact

• Title: Dr. Moustafa Ibrahim
• Organization: Assistant professor of Obstetrics & Gynecology, Ain-shams faculty of medicine

mi_monem@yahoo.com

00201001955996

Study Officials

• 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

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: June 18, 2012
• First Posted: June 19, 2012
• Study Start: June 1, 2011
• Primary Completion: January 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 7, 2017
• Results First Posted: February 7, 2013

Record last verified: 2017-03

Locations

EG (1)