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

NCT06490419 | Not Yet Recruiting

• 1 other identifier: P.T.REC/012/004229
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

electrolipolysis group

EXPERIMENTAL

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

Device: Electrolipolysis

ultrasound cavitation group

EXPERIMENTAL

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

Device: ultrasound cavitation

Interventions

Electrolipolysis 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.

electrolipolysis group

ultrasound cavitation 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.

ultrasound cavitation group

Eligibility Criteria

• Age: 25 Years - 35 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Afaf Botla, PHD

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Hend Hassan, Master

CONTACT

+2 01064009189; alfatimiaclinic@gmail.com

Mahitab Yosri, PHD

CONTACT

+2 01222606996; lilmahy_2010@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 30, 2024
• First Posted: July 8, 2024
• Study Start: July 10, 2024
• Primary Completion: November 1, 2024
• Study Completion: December 10, 2024
• Last Updated: July 9, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL