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

Effect of Ultrasound Cavitation Versus Electrolipolysis on Obese Infertile Women With Polycystic Ovarian Syndrome: a Randomized Controlled Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Device: Electrolipolysis; Device: ultrasound cavitation

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hend Hassan, Master; Phone Number: +2 01064009189; Email: alfatimiaclinic@gmail.com
• Study Contact Backup: Name: Mahitab Yosri, PHD; Phone Number: +2 01222606996; Email: lilmahy_2010@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: electrolipolysis group; The participants will be treated by electrolipolysis, in addition to the low-caloric diet of 1200 kcal/day.	Device: Electrolipolysis; Hypocaloric diet: All patients were prescribed balanced hypocaloric diet (1200 kcal/day) by the nutrition specialist, with physiological nutrient content: carbohydrates-50%, proteins-20%, fats-30% and fiber daily consumption of 30 - 40 g in dry form (grain and vegetables). Calorie distribution: breakfast-40%, lunch-40%, dinner-20%. Behavioral therapy to correct eating disorders: diary of food and lifestyle, motivational phone calls every week Electrolipolysis: the participants will receive electrolipolysis applied to abdomen, thigh and gluteal regions, 3 sessions/week, for 3 months, 60 minutes/session; 30 minutes on the abdomen and thigh and 30 minutes on gluteal region. the device will be set to cause a contraction for 4 seconds followed by a relaxation for 4 seconds with a pulse width of 400 microseconds and a frequency of 20 pulses per minute.
Experimental: ultrasound cavitation group; The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1200 kcal/day.	Device: ultrasound cavitation; Hypocaloric diet: All patients were prescribed balanced hypocaloric diet (1200 kcal/day) by the nutrition specialist, as in the electrolipolysis group. ultrasound cavitation (UC): The participants will be treated by UC on the abdomen for 30 minutes, two sessions per week for 3 months. From standing position, the abdominal area of each patient will be divided transversally into 3 parts; part I: from the xiphoid process to 3 cm above the umbilicus, part II: from 3cm above the umbilicus to 2 cm below the umbilicus and part III: from 2 cm below the umbilicus to the pubic bone. Vertically, each part will be divided into right and left segments in relation to the linea alba, forming a total of 6 abdominal segments. The program of cavitation; frequency (40 kHz) will be chosen, the time will be adjusted at 30 minutes. The cavitational head will be, then, moved very slowly on each abdominal segment in a small circular movement for 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight, height and BMI measurements	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)	within 3 months
Waist hip Ratio	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.	within 3 months
LH/ FSH Ratio	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	within 3 months
Ovulation rate	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	within 3 months

Collaborators and Investigators

• Sponsor: Cairo University
• Investigators: Study Director: Afaf Botla, PHD, Cairo university

Study record dates

Study Major Dates

• Study Start (Estimated): July 10, 2024
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 10, 2024

Study Registration Dates

• First Submitted: June 30, 2024
• First Submitted That Met QC Criteria: June 30, 2024
• First Posted (Actual): July 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 9, 2024
• Last Update Submitted That Met QC Criteria: July 6, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: P.T.REC/012/004229

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No