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

NCT06490419 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-09

No results posted yet for this study

Summary

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

Conditions

  • Polycystic Ovary Syndrome

Interventions

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.

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Principal Investigators

  • Afaf Botla, PHD · Cairo University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
25 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2024-11-01
Completion
2024-12-10

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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 NCT06490419 on ClinicalTrials.gov