search
Back to results

PCOS and US Cavitation

Primary Purpose

PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ultrasound cavitation in addition to aerobic ex
aerobic exercises.
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria All women in this study will be on the following criteria: Their ages will range from 20-35 years. They will be diagnosed with PCOS by Gynecologist. Doesn't receive any treatment for menstrual regularity and fertility during the study. BMI above 25kg/m²and less than 35kg/m². Waist /hip ratio <.88. Exclusion Criteria Women will be excluded if they have one of the following criteria: Skin diseases that prevent the application of cavitation. Severe cardiovascular disease. Other endocrine disordered (hypothyroidism hyperprolactinemia). Patients that who take hormonal treatment within the last 3 months before the study.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    study group

    control group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Infertily related Stress level
    fertility problem inventory scale will be used for assessing the stress level pre and post treatment.
    cortisol level
    Saliva samples will be collected with study participants sitting upright in a comfortable position and tilting the head forward, allowing the saliva to pool on the floor of the mouth

    Secondary Outcome Measures

    Anthrometric measurement (BMI And waist hip ratio)
    BMI and waist/hip ratio Measurements of BMI in which the weight in kilograms divided by the square of the heights in meters and waist to hip circumference measured with a soft tape at the level of the umbilicus and the anterior superior iliac spine with woman in the standing position, were made before treatment and after the end of the study period
    Hormonal profile (LH- FSH - LH /FSH ratio).
    Blood samples will be drown from an antecubital vein of each patient in the study on two occasions, firstly at the end at 2 nd or 3 rd day of the menstrual cycle after an overnight fasting just before starting her treatment regimen and secondly after 3 months of the treatment. It will be centrifuged within 2 hours after withdrawal. Serum will be stared at -20OC and assayed for LH and FSH with chemiluminescent enzyme immunoassay kits. Assays for fasting insulin by RIA kits and SHBG will be determined by using an immunoradiometric assay (IRMA).

    Full Information

    First Posted
    May 19, 2023
    Last Updated
    May 19, 2023
    Sponsor
    Cairo University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05880550
    Brief Title
    PCOS and US Cavitation
    Official Title
    Response of Menstrual Irregularity and Infertility- Related Stress to Ultrasound Cavitation Combined With Aerobic Exercise in PCOS: Double Blinded Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 25, 2023 (Anticipated)
    Primary Completion Date
    August 25, 2023 (Anticipated)
    Study Completion Date
    September 25, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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. Recent research stated that interventions aiming to improve QoL among infertile women with PCOS should focus on alleviating infertility-related stress, especially among women with high BMI. So, the purpose of this study is to investigate the effect of ultrasound cavitation combined with aerobic exercise on menstrual irregularity and infertility related stress in women having PCOS.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    study group
    Arm Type
    Experimental
    Arm Title
    control group
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    ultrasound cavitation in addition to aerobic ex
    Intervention Description
    Ultrasonic cavitation was turned on, the program of cavitation 40 kHz was chosen, the time was adjusted at 30 minutes. The cavitational head was moved very slowly on each abdominal segment in a small circular movement for 5 minutes. After finishing the focused ultrasound of the 6 segments of the abdomen, the skin was cleaned with cotton. in addition to that the patients will receive aerobic exercises for 40 minutes.
    Intervention Type
    Other
    Intervention Name(s)
    aerobic exercises.
    Intervention Description
    the patients will do aerobic training for 40 minutes on a bicycle ergometer.
    Primary Outcome Measure Information:
    Title
    Infertily related Stress level
    Description
    fertility problem inventory scale will be used for assessing the stress level pre and post treatment.
    Time Frame
    change from base line at 12 weeks.
    Title
    cortisol level
    Description
    Saliva samples will be collected with study participants sitting upright in a comfortable position and tilting the head forward, allowing the saliva to pool on the floor of the mouth
    Time Frame
    change from base line at 12 weeks.
    Secondary Outcome Measure Information:
    Title
    Anthrometric measurement (BMI And waist hip ratio)
    Description
    BMI and waist/hip ratio Measurements of BMI in which the weight in kilograms divided by the square of the heights in meters and waist to hip circumference measured with a soft tape at the level of the umbilicus and the anterior superior iliac spine with woman in the standing position, were made before treatment and after the end of the study period
    Time Frame
    change from base line at 12 weeks.
    Title
    Hormonal profile (LH- FSH - LH /FSH ratio).
    Description
    Blood samples will be drown from an antecubital vein of each patient in the study on two occasions, firstly at the end at 2 nd or 3 rd day of the menstrual cycle after an overnight fasting just before starting her treatment regimen and secondly after 3 months of the treatment. It will be centrifuged within 2 hours after withdrawal. Serum will be stared at -20OC and assayed for LH and FSH with chemiluminescent enzyme immunoassay kits. Assays for fasting insulin by RIA kits and SHBG will be determined by using an immunoradiometric assay (IRMA).
    Time Frame
    change from base line at 12 weeks.

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria All women in this study will be on the following criteria: Their ages will range from 20-35 years. They will be diagnosed with PCOS by Gynecologist. Doesn't receive any treatment for menstrual regularity and fertility during the study. BMI above 25kg/m²and less than 35kg/m². Waist /hip ratio <.88. Exclusion Criteria Women will be excluded if they have one of the following criteria: Skin diseases that prevent the application of cavitation. Severe cardiovascular disease. Other endocrine disordered (hypothyroidism hyperprolactinemia). Patients that who take hormonal treatment within the last 3 months before the study.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    marwa S saleh
    Phone
    01008342466
    Email
    marwa_shafiek2000@yahoo.com

    12. IPD Sharing Statement

    Learn more about this trial

    PCOS and US Cavitation

    We'll reach out to this number within 24 hrs