EFFECT OF CRYOLIPOLYSIS ON HORMONAL PROFILE AND MENSTRUAL REGULARITYIN OBESE WITH PCOS

NCT ID: NCT06226701

Last Updated: 2024-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2023-12-01

Brief Summary

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

Conditions

Obese Women With PCOS

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Impact of cryolipolsis on hormonal profile in obese women with pcos

The patients will receive cryolipolysis session in abdomen for 45minute ,session every two week and 1200kcal diet and exercise for 3 months

Group Type: EXPERIMENTAL

Cryolipolysis device

Intervention Type: 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.

Impact of cryolipolysis in hormonal profile in obese women with pcos

All patient will receive same diet 1200kcal diet ,and exercise for 3 months

Group Type: EXPERIMENTAL

Cryolipolysis device

Intervention Type: 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.

Interventions

Cryolipolysis 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.

Intervention Type: DEVICE

Other Intervention Names

max freeze device

Eligibility Criteria

Inclusion Criteria

All patient age from 18to 30 Waist hip ratio >.9

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Sabrin Mohamed Taha Abdelwahab

OTHER

Sponsor Role: lead

Responsible Party

Sabrin Mohamed Taha Abdelwahab

Principle investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Sabrin mohamed taha abdelwahab

Bilbeis, Sharqia Province, Egypt

Countries

Egypt

Other Identifiers

P.tRec/012/004763

Identifier Type: -

Identifier Source: org_study_id