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

EFFECT OF CRYOLIPOLSIS IN HORMONAL PROFILE AND MENSTRUAL REGULARITY IN OBESE WOMEN WITH PCOS

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06226701
Enrollment
50
Registered
2024-01-26
Start date
2023-09-01
Completion date
2023-12-01
Last updated
2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obese Women With PCOS

Keywords

obesity, pcos ,cryolipolysis

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

Interventions

DEVICECryolipolysis 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.

Sponsors

Sabrin Mohamed Taha Abdelwahab
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

Masking description

Double (participant,outcomes assessed random generator

Intervention model description

Impact of cryolipolsis on hormonal Profile in obese women with Pcps

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 30 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
WeightUp to 3monthsthe scale will asses the weight of patient
Hormones3monthsblood sample will take by lab before and after treatment

Secondary

MeasureTime frameDescription
waist hip ratio3monthswaist-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.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026