Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04745338
• Other study ID #: ECVAPP
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: February 2021
• Source: Cairo University
• Contact: miral mo saleh, md
• Phone: 01200678845
• Email: marmooramido[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

Description:

This study will be carried out on sixty females with polycystic ovarian syndrome (PCOS) who were selected from the Outpatient Clinic of Gynecology at Qasr Al Aini University Hospital. Their age ranged from 17-28 years, body mass index was 25-30 Kg/m2. They experienced hyperandrogenism, hyperinsulinemia and amenorrhea not less than 6 months.

PCOS females will be randomly assigned into two equal groups: group (A) (control group) consisted of 30 women who received low caloric diet (1200 Cal/day) and group (B) (study group) consisted of 30 women who received the same diet regime and cryolipolysis

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: February 28, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 28 Years

Eligibility

Inclusion Criteria:

• age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome .

Exclusion Criteria:

• Diabetic patients.

• Women with BMI>30

• Women having circulatory dysfunction.

• Women with respiratory or cardiac disease

• liver disease.

• Skin disease .

• Previous abdominal or uterine surgery

• Physical impairment

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

Device:
• 3max cool shaping device
cryolipolysis sessions are applied on abdomen area each session for 40 min. each

Dietary Supplement:
• low calolric diet
low caloric diet (1200cal/day)

Locations

Country	Name	City	State
Egypt	Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visceral adiposity index	indicator of adipose tissue distribution	3 months
Secondary	weight	anthropometric measurement by kilogram (kg)	up to 3 months
Secondary	waist circumference	anthropometric measurement by centimeter (cm)	up to 3 months
Secondary	high density lipoprotein	blood test	up to 3 months
Secondary	serum triglyceride level	blood test	up to 3months