NCT04745338

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 9, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

March 1, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2022

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

11 months

First QC Date

February 3, 2021

Last Update Submit

February 4, 2021

Conditions

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Visceral adiposity index

    indicator of adipose tissue distribution

    3 months

Secondary Outcomes (4)

  • weight

    up to 3 months

  • waist circumference

    up to 3 months

  • high density lipoprotein

    up to 3 months

  • serum triglyceride level

    up to 3months

Study Arms (2)

low caloric diet

PLACEBO COMPARATOR

low caloric diet (1200cal/day)

Dietary Supplement: low calolric diet

cryolipolysis

ACTIVE COMPARATOR

cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device

Device: 3max cool shaping deviceDietary Supplement: low calolric diet

Interventions

3max cool shaping deviceDEVICE

cryolipolysis sessions are applied on abdomen area each session for 40 min. each

cryolipolysis
low calolric dietDIETARY_SUPPLEMENT

low caloric diet (1200cal/day)

cryolipolysislow caloric diet

Eligibility Criteria

Age20 Years - 28 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsit is carried on women with dysfunction in ovaries
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cairo University

Cairo, 14788, Egypt

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Study Officials

  • fahema me okiel, phd

    Cairo University

    STUDY DIRECTOR

  • amal mo youssef, phd

    Cairo University

    STUDY CHAIR

Central Study Contacts

miral mo saleh, md

CONTACT

01200678845marmooramido@gmail.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
ASSISTANT LECTURER

Study Record Dates

First Submitted

February 3, 2021

First Posted

February 9, 2021

Study Start

March 1, 2021

Primary Completion

January 30, 2022

Study Completion

February 28, 2022

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)