Clinical trial NCT01622257: Cavitation Ultrasound in Treatment of Patients With PCOS
Official title: Comparison of Cavitation Ultrasound, Metformin or the Combination of Both in Obese Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: PCOS
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2012-06-19
Enrollment: 198
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Obese infertile polycystic ovarian syndrome (PCOS) women

Exclusion Criteria:

* 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

Primary outcomes:
measure: Clinical Pregnancy Rate
timeFrame: 9 months
Secondary outcomes:
measure: Ovulation Rate as Determined by Ultrasonographic Folliculometry and Luteal Serum Progesterone Assay.
timeFrame: 3 months
measure: Change in Insulin Resistance
timeFrame: Baseline and 3 months
measure: Change in Serum Free Testosterone Level
timeFrame: Baseline and 3 months
measure: Change in Lipid Profile
timeFrame: Baseline and 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: Ain Shams University
name: Mostafa I. Ibrahem, M.D.
role: STUDY_DIRECTOR
affiliation: Lecturer Obstetics & Gynecology Ain shams university faculty of medicine
name: Mohamed I. Ellaithy, MD
role: STUDY_CHAIR
affiliation: Assistant professor of Obstetrics & Gynecology Ain shams university faculty of medicine
name: Ahmed K. Makled, MD
role: PRINCIPAL_INVESTIGATOR
References: