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

NCT ID: NCT06490419

Last Updated: 2024-07-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-10
• Study Completion Date: 2024-12-10

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.

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

electrolipolysis group

The participants will be treated by electrolipolysis, in addition to the low-caloric diet of 1200 kcal/day.

Group Type: EXPERIMENTAL

Electrolipolysis

Intervention Type: DEVICE

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.

ultrasound cavitation group

The participants will be treated by ultrasound cavitation, in addition to the low-caloric diet of 1200 kcal/day.

Group Type: EXPERIMENTAL

ultrasound cavitation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Hend Ahmed Hassan

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Afaf Botla, PHD

Role: STUDY_DIRECTOR

Cairo University

Central Contacts

Hend Hassan, Master

Role: CONTACT

alfatimiaclinic@gmail.com

+2 01064009189

Mahitab Yosri, PHD

Role: CONTACT

lilmahy_2010@hotmail.com

+2 01222606996

Other Identifiers

P.T.REC/012/004229

Identifier Type: -

Identifier Source: org_study_id