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

Cairo University (CU)

Status: Not yet enrolling

Conditions: Polycystic Ovary Syndrome

Treatments: Device: ultrasound cavitation; Device: Electrolipolysis

Study type: Interventional

Funder types: Other

Identifiers

NCT06490419

P.T.REC/012/004229

Details and patient eligibility

About

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

Full 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.

Enrollment: 30 estimated patients

Sex: Female

Ages: 25 to 35 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

30 participants in 2 patient groups

electrolipolysis group

Experimental group

Description:

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

Treatment:

Device: Electrolipolysis

ultrasound cavitation group

Experimental group

Description:

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

Treatment:

Device: ultrasound cavitation