Polycystic Ovary SyndromeNCT04745338
Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
A study testing 3max cool shaping device and low calolric diet in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
Trial summary
this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial Read more about this study
- Who is it for?
- Ages 20 to 28 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome
- What is being tested?
- 3max cool shaping device and low calolric diet
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 28 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome .
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 14788
miral s mohamed, md, 01200678845 ext. +012, marmooramido@gmail.com
About this study
this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial
Read the detailed 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
- Conditions
- Polycystic Ovary Syndrome
- Being tested
- 3max cool shaping device, low calolric diet
- Medical subject headings
- Polycystic Ovary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3max cool shaping deviceDevice
cryolipolysis sessions are applied on abdomen area each session for 40 min. each
low calolric dietDietary supplement
low caloric diet (1200cal/day)
| Study group | Role | What they receive |
|---|---|---|
| low caloric diet | Placebo comparator | low caloric diet (1200cal/day) Receives: Dietary Supplement: low calolric diet |
| cryolipolysis | Active comparator | cryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device Receives: Device: 3max cool shaping device; Dietary Supplement: low calolric diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visceral adiposity index
indicator of adipose tissue distribution
Measured: 3 months
Secondary outcomes (4)
weight
anthropometric measurement by kilogram (kg)
Measured: up to 3 months
waist circumference
anthropometric measurement by centimeter (cm)
Measured: up to 3 months
high density lipoprotein
blood test
Measured: up to 3 months
serum triglyceride level
blood test
Measured: up to 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2021
- Study start1 Mar 2021 (estimated)
- Primary completion30 Jan 2022 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Miral Saleh Mohamed, Cairo University
- Investigators
- fahema me okiel, phd, Study director, Cairo Universityamal mo youssef, phd, Study chair, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04745338
- Sponsor's protocol ID
- ECVAPP
- Status last verified
- Feb 2021
- First submitted
- 3 Feb 2021
- Last updated
- 9 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Cryolipolysis On Visceral Adiposity Index In Polycystic Ovarian Syndrome Patients
- ClinicalTrials.gov ID
- NCT04745338
- Acronym / sponsor ID
- ECVAPP
- Conditions
- Polycystic Ovary Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (estimated)
- Primary completion
- 30 Jan 2022 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 9 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| low caloric diet | Placebo comparator | Dietary Supplement: low calolric dietlow caloric diet (1200cal/day) |
| cryolipolysis | Active comparator | Device: 3max cool shaping device, Dietary Supplement: low calolric dietcryolipolysis 3 sessions one session every 6 weeks by 3max cool shaping device |
Who may qualify
- Ages
- 20 to 28 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age ranges from 20-28 years, body mass index ranges 25-30 Kg/m2. They have pco syndrome .
Key exclusion criteria (8 listed)
- Diabetic patients.
- Women with BMI>30
- Women having circulatory dysfunction.
- Women with respiratory or cardiac disease
- liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3max cool shaping devicecryolipolysis sessions are applied on abdomen area each session for 40 min. each | Device | cryolipolysis |
| low calolric dietlow caloric diet (1200cal/day) | Dietary supplement | cryolipolysis, low caloric diet |
Primary outcome
Visceral adiposity index
Time frame: 3 months
indicator of adipose tissue distribution
4 secondary outcomes
weight
Time frame: up to 3 months
waist circumference
Time frame: up to 3 months
high density lipoprotein
Time frame: up to 3 months
serum triglyceride level
Time frame: up to 3months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
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The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
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The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
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Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fahema me okiel, phd study director
Cairo University
amal mo youssef, phd study chair
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3max cool shaping device and low calolric diet in people with Polycystic Ovary Syndrome, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact miral mo saleh, md (01200678845 ext. +012, marmooramido@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visceral adiposity index (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021.