Obese Women With PCOSNCT06226701
EFFECT OF CRYOLIPOLYSIS ON HORMONAL PROFILE AND MENSTRUAL REGULARITYIN OBESE WITH PCOS
A study testing Cryolipolysis device in people with Obese Women With PCOS, run by Sabrin Mohamed Taha Abdelwahab at 1 site in Egypt.
Trial summary
The effecting study to determine the impact of cryolipolysis on obese women with pcos Read more about this study
- Who is it for?
- Ages 18 to 30 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obese Women With PCOS
- What is being tested?
- Cryolipolysis device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2023to 1 Dec 2023
- 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 18 to 30 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- All patient age from 18to 30 Waist hip ratio >.9
Who cannot join
- thyroid disorders. Hepatic diseases. Skin or bleeding disorders. Chronic disease or illnessCardiovascular and pulmonary disease,Cancer diseases., Renal failure disease. Recent surgery. hose with pacemakers or surgical implants. Musculoskeletal problems that would limit WBV.Raynaud's phenomenon. A rare condition in which cold temperatures can impede blood flow to the fingers and toes. Other conditions that pose a risk include,Pregnancy or breast-feeding,Inflammatory skin disorders,Skin conditions caused by immune system disorders, such as eczema or psoriasis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: EFFECT OF CRYOLIPOLSIS IN HORMONAL PROFILE AND MENSTRUAL REGULARITY IN OBESE WOMEN WITH PCOS
The effecting study to determine the impact of cryolipolysis on obese women with pcos
Read the detailed description
Polycystic ovary syndrome(PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive.The etiology of PCOS is unclear. Early diagnosis and treatment may reduce the risk of long-term complications such as type 2 diabetes and heart disease ,PCOS affects 5-20% of women of reproductive age worldwide. The condition is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovarian morphology (PCOM) with excessive androgen production by the ovaries being a key feature of PCOS. PCOS is classified into four separate phenotypes (A-D), according to the presence or absence of three characteristics: hyperandrogenism (either biochemical or clinical), ovulatory dysfunction and polycystic ovarian morphology. Only phenotype A requires all three features of PCOS to be present. The various diagnostic criteria currently available for PCOS include a greater or fewer number of PCOS phenotypes. AE-PCOS, Androgen Excess-PCOS Society; NIH, National Institutes of Health ,the trial made on 2group ,control group and study group for 3 months
- Conditions
- Obese Women With PCOS
- Being tested
- Cryolipolysis device
- Keywords
- obesity, pcos ,cryolipolysis
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cryolipolysis deviceDevice
Also called max freeze device
-Cryolipolysis device
1max cool shaping device ( inform china korean technology).Is used for fat lipolysis ,with no harm to the skin.The device consist of Cool sculptor applicator head , cool gel pad its alarge gel pad it should be adherent to the area to be treated before applying the cool sculptor applicator to protect the skin from bruising or ecchymosis. The device uses vacuum suction which can be adjusted according to the patient tolerance. Duration of session 45min at each of treatment session ,1session every 2weeks for 3months.
| Study group | Role | What they receive |
|---|---|---|
| Impact of cryolipolsis on hormonal profile in obese women with pcos | Experimental | The patients will receive cryolipolysis session in abdomen for 45minute ,session every two week and 1200kcal diet and exercise for 3 months Receives: Device: Cryolipolysis device |
| Impact of cryolipolysis in hormonal profile in obese women with pcos | Experimental | All patient will receive same diet 1200kcal diet ,and exercise for 3 months Receives: Device: Cryolipolysis device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
the scale will asses the weight of patient
Measured: Up to 3months
Hormones
blood sample will take by lab before and after treatment
Measured: 3months
Secondary outcomes (1)
waist hip ratio
waist-hip ratio or waist-to-hip ratio (WHR) is the dimensionless ratio of the circumference of the waist to that of the hips. This is calculated as waist measurement divided by hip measurement (W⁄H). For example, a person with a 75 cm waist and 95 cm hips (or a 30-inch waist and 38-inch hips) has WHR of about 0.79.
Measured: 3months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2024
- Study start1 Sep 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese Women With PCOSStudies of the same condition, open and under way.
- 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
- Model description
- Impact of cryolipolsis on hormonal Profile in obese women with Pcps
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabrin Mohamed Taha Abdelwahab
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabrin Mohamed Taha Abdelwahab, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06226701
- Sponsor's protocol ID
- P.tRec/012/004763
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 26 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EFFECT OF CRYOLIPOLSIS IN HORMONAL PROFILE AND MENSTRUAL REGULARITY IN OBESE WOMEN WITH PCOS
- ClinicalTrials.gov ID
- NCT06226701
- Acronym / sponsor ID
- P.tRec/012/004763
- Conditions
- Obese Women With PCOS
- Keywords
- obesity, pcos ,cryolipolysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sabrin Mohamed Taha AbdelwahabUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 26 Jan 2024 (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.
The effecting study to determine the impact of cryolipolysis on obese women with pcos
Detailed description
Polycystic ovary syndrome(PCOS) is the most common endocrine disorder in women of reproductive age. Women with this syndrome may have infrequent menstrual periods or amenorrhea and excess androgen levels. The ovaries develop numerous small follicles and fail to ovulate on a regular basis, with subsequent subfertility in those women that wish to conceive.The etiology of PCOS is unclear. Early diagnosis and treatment may reduce the risk of long-term complications such as type 2 diabetes and heart disease ,PCOS affects 5-20% of women of reproductive age worldwide. The condition is characterized by hyperandrogenism, ovulatory dysfunction and polycystic ovarian morphology (PCOM) with excessive androgen production by the ovaries being a key feature of PCOS. PCOS is classified into four separate phenotypes (A-D), according to the presence or absence of three characteristics: hyperandrogenism (either biochemical or clinical), ovulatory dysfunction and polycystic ovarian morphology. Only phenotype A requires all three features of PCOS to be present. The various diagnostic criteria currently available for PCOS include a greater or fewer number of PCOS phenotypes. AE-PCOS, Androgen Excess-PCOS Society; NIH, National Institutes of Health ,the trial made on 2group ,control group and study group for 3 months
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Impact of cryolipolsis on hormonal Profile in obese women with Pcps
| Arm | Type | Receives |
|---|---|---|
| Impact of cryolipolsis on hormonal profile in obese women with pcos | Experimental | Device: Cryolipolysis deviceThe patients will receive cryolipolysis session in abdomen for 45minute ,session every two week and 1200kcal diet and exercise for 3 months |
| Impact of cryolipolysis in hormonal profile in obese women with pcos | Experimental | Device: Cryolipolysis deviceAll patient will receive same diet 1200kcal diet ,and exercise for 3 months |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patient age from 18to 30 Waist hip ratio >.9
Key exclusion criteria (1 listed)
- thyroid disorders. Hepatic diseases. Skin or bleeding disorders. Chronic disease or illnessCardiovascular and pulmonary disease,Cancer diseases., Renal failure disease. Recent surgery. hose with pacemakers or surgical implants. Musculoskeletal problems that would limit WBV.Raynaud's phenomenon. A rare condition in which cold temperatures can impede blood flow to the fingers and toes. Other conditions that pose a risk include,Pregnancy or breast-feeding,Inflammatory skin disorders,Skin conditions caused by immune system disorders, such as eczema or psoriasis
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 |
|---|---|---|
| Cryolipolysis deviceAlso: max freeze device-Cryolipolysis device 1max cool shaping device ( inform china korean technology).Is used for fat lipolysis ,with no harm to the skin.The device consist of Cool sculptor applicator head , cool gel pad its alarge gel pad it should be adherent to the area to be treated before applying the cool sculptor applicator to protect the skin from bruising or ecchymosis. The device uses vacuum suction which can be adjusted according to the patient tolerance. Duration of session 45min at each of treatment session ,1session every 2weeks for 3months. | Device | Impact of cryolipolsis on hormonal profile in obese women with pcos, Impact of cryolipolysis in hormonal profile in obese women with pcos |
Primary outcome
Weight
Time frame: Up to 3months
the scale will asses the weight of patient
Hormones
Time frame: 3months
blood sample will take by lab before and after treatment
1 secondary outcome
waist hip ratio
Time frame: 3months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2024.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryolipolysis device in people with Obese Women With PCOS, run by Sabrin Mohamed Taha Abdelwahab 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 1 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: finished, as of the sponsor's last update on 26 Jan 2024. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: Up to 3months). The study lists 2 primary outcomes in all. 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 26 Jan 2024.