Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome

Not Applicable

Not yet recruiting

• Conditions: Polycystic Ovary Syndrome
• Interventions: Device: ultrasound cavitation; Device: Electrolipolysis

• Registration Number: NCT06490419
• Lead Sponsor: Cairo University

Brief Summary

This study aims to determine the difference between the effect of ultrasound cavitation and electrolipolysis on obese infertile women with polycystic ovarian syndrome.

Detailed Description

Polycystic ovarian syndrome (PCOS) is the most prevalent endocrinopathy among women during reproductive age . PCOS affects 5-10% of women in reproductive age. It has an effect on quality of life , fertility and pregnancy.

Obesity plays a significant role in reproductive disorders, particularly in women. It is associated with anovulation, menstrual disorders, infertility, difficulties in assisted reproduction, miscarriage, and adverse pregnancy outcomes.

The treatment of obesity and infertility causes some harm to women, due to the danger of some operations and medications other than the high cost of these operations, so it is necessary to use a therapeutic alternative that is non invasive, with lower risk and lower cost.

Both ultrasound cavitation (UC) and electrolipolysis are non invasive modalities with many positive effects on obesity and PCOS outcomes. The effect of both the UC and electrolipolysis has been separately investigated in previous studies. Though, no studies were found to compare the effect of both modalities in the management of infertile women with PCOS. Therefore, this study will be conducted to explore the effect of UC versus electrolipolysis on infertile women with PCOS.

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2024-06-30
• Study First Submitted QC: 2024-06-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-06
• Study First Posted: 2024-07-08
• Last Update Posted: 2024-07-09
• Study Start: 2024-07-10
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

• Infertile married PCOS women, diagnosed by Rotterdam criteria .
• Their ages will be ranged between 25-35 year old.
• Their BMI will be ranged from 30-40 kg/ m2.
• Their waist/hip ratio equal to or more than 0.85

Read More

Exclusion Criteria

• Thyroid dysfunction (hypothyroidism).
• Chronic and/or systemic illnesses (e.g. diabetes mellitus, liver, renal respiratory failure and cardiovascular disorders).
• Malignant tumors.
• Tubal adhesions as well as uterine abnormalities.
• Skin diseases in the abdominal and gluteal regions.
• Conditions that may prevent the use of electrical stimulation.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ultrasound cavitation group	ultrasound cavitation	The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1200 kcal/day.
electrolipolysis group	Electrolipolysis	The participants will be treated by electrolipolysis, in addition to the low-caloric diet of 1200 kcal/day.

Primary Outcome Measures

Name	Time	Method
Waist hip Ratio	within 3 months	To accurately measure central obesity, waist/hip ratio will be measured by tape measurement. Waist circumference will be measured at the narrowest portion of the torso approximately midway between the lower costal margin and the iliac crest. The hip circumference will be measured over the widest portion of the gluteal and greater trochanteric region then the ratio between them will be calculated. Reference of female measurements for central obesity will be a waist circumference of \>88 cm and a waist-hip ratio \>0.85.
Weight, height and BMI measurements	within 3 months	Weight/ height scale will be used to measure the weight and height of all females in both groups to calculate their BMI before and after treatment according to the following equation BMI = weight/height2 (kg/ m2)
LH/ FSH Ratio	within 3 months	ELISA kites will be used for assessing serum luteinizing hormone (LH) and follicular stimulating hormone (FSH) to calculate LH/ FSH ratio. Blood samples will be drawn from antecubital vein of each patient before and after treatment. It will be centrifuged within 2 hours after withdrawal. Serum will be stared at -20°C and assayed for LH/ FSH Ratio. They will be measured in the third day of the menstrual cycle but will be measured in the luteal phase
Ovulation rate	within 3 months	Abdominal ultrasongraphy will be used to assess ovarian volume before and after treatment for measuring ovulation rate. A minimum of 12 follicles with a diameter of 2 to 9 mm in each ovary, as well as a rising ovarian volume with a minimum size of 10 mm, are the criteria required for an ultrasound diagnosis of defective ovulation