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Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs

Primary Purpose

Polycystic Ovary Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound cavitation in group A
Electro acupuncture in group B
Sponsored by
Mohamed Abdel Hamid elgaedy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Their ages will be ranged between 20-35 year old.
  2. Their body mass index will be ranged from 30-40 kg/m2.
  3. All of them are married women.

Exclusion Criteria:

  • Women will be excluded if they have one of the following criteria:

    1. Diabetes mellitus.
    2. Thyroid dysfunction.
    3. Concomitant cardiovascular disorders.
    4. Respiratory, renal and liver dysfunction.
    5. Tubal adhesions as well as uterine abnormalities.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Group USC

    Group EA

    Arm Description

    Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome

    Effect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome

    Outcomes

    Primary Outcome Measures

    weight
    It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.
    waist/hip ratio:
    It will be use tape measurement to calculate the waist/hip ratio.
    Testosterone hormones :
    They will be use kites for assessment of level of testosterone hormones
    FSH Hormone
    They will be use kites for assessment of level of FSH hormones
    Lh hormones
    They will be use kites for assessment of level of LH hormones
    Progesterone hormones
    They will be use kites for assessment of level of progesterone hormones
    Height
    It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.

    Secondary Outcome Measures

    Ovulation rate
    It will be use ultrasonography for measuring ovulation rate.

    Full Information

    First Posted
    April 19, 2021
    Last Updated
    May 5, 2021
    Sponsor
    Mohamed Abdel Hamid elgaedy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04875312
    Brief Title
    Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs
    Official Title
    Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 30, 2021 (Anticipated)
    Primary Completion Date
    July 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Mohamed Abdel Hamid elgaedy

    4. Oversight

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

    5. Study Description

    Brief Summary
    The aim of this study is to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome …………………………………………………………………… BACKGROUND: Polycystic ovary syndrome (PCOS) is a common endocrine and metabolic disorder that occurs in 6 - 10% of women at the reproductive age. It is associated with an-ovulation, infertility, hyperandrogenism, obesity and insulin resistance. Endocrine characteristics of PCOS are elevated serum concentrations of androgens and Luteinizing hormone (LH) and decreased concentrations of sex hormone binding globulin (SHBG). Ultrasound cavitation is the method in handling Subcutaneous Adipose Tissue (, especially in destroying subcutaneous fat and shaping a particular part of the body. As one of the non-surgical correction method, UC is preferred for lowering the risk of complications due to obesity. UC reported a greater decrease of the WHR, suggesting a valuable modification of fat distribution pattern, especially at the abdominal level. It improves rates of ovulation, provides higher incidence of regular menstrual cycles and lower levels of total testosterone. Acupuncture is a treatment method used in Traditional Chinese Medicine. Electroacupuncture promotes follicle development and corrects reproductive endocrine dysfunction in ovaries by regulating the functions of the hypothalamus, pituitary and ovaries
    Detailed Description
    This study will be designed as prospective, randomized, single blind, experimental, pre-post test , controlled- trial study. Simple Size Calculation: I- Subjects: Forty obese infertile patients with poly cystic ovarian syndrome will participate in this study to determine the difference between the effect of Ultrasound Cavitation and Elctroacupuncture on sex hormones. They will be selected randomly from Out Patient Clinic of Aga Hospital Central, in Aga. All patients will be divided randomly into two equal groups (A&B). Group A: twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) Group B: twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day) II- Instrumentations: Recording data sheet (Appendix II). Standard weight height scale: measure BMI Tape measurement: measure waist/hip ratio. Test tubes: used to collect the blood samples from obese infertile patients Kites: used for assessment of serum progesterone level, testosterone, LH and FSH. Abdominal ultrasongraphy: measure ovulation rate. cavitation in group A 8- electroacupuncture in group B

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Polycystic Ovary Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group USC
    Arm Type
    Experimental
    Arm Description
    Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome
    Arm Title
    Group EA
    Arm Type
    Experimental
    Arm Description
    Effect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound cavitation in group A
    Intervention Description
    Group A: twenty obese infertile patients with PCO who will be treated by ultrasound cavitation, 2 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
    Intervention Type
    Device
    Intervention Name(s)
    Electro acupuncture in group B
    Intervention Description
    Group B: twenty obese infertile patients with PCO who will be treated by electroacupuncture, 3 times per week for 3 months with medical treatment and hypocaloric diet (1200 kcal/day)
    Primary Outcome Measure Information:
    Title
    weight
    Description
    It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.
    Time Frame
    up to 12 weeks
    Title
    waist/hip ratio:
    Description
    It will be use tape measurement to calculate the waist/hip ratio.
    Time Frame
    up to 12 weeks
    Title
    Testosterone hormones :
    Description
    They will be use kites for assessment of level of testosterone hormones
    Time Frame
    up to 12 weeks
    Title
    FSH Hormone
    Description
    They will be use kites for assessment of level of FSH hormones
    Time Frame
    up to 12 weeks
    Title
    Lh hormones
    Description
    They will be use kites for assessment of level of LH hormones
    Time Frame
    up to 12 weeks
    Title
    Progesterone hormones
    Description
    They will be use kites for assessment of level of progesterone hormones
    Time Frame
    up to 12 weeks
    Title
    Height
    Description
    It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.
    Time Frame
    up to 12 weeks
    Secondary Outcome Measure Information:
    Title
    Ovulation rate
    Description
    It will be use ultrasonography for measuring ovulation rate.
    Time Frame
    up to 12 weeks

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Their ages will be ranged between 20-35 year old. Their body mass index will be ranged from 30-40 kg/m2. All of them are married women. Exclusion Criteria: Women will be excluded if they have one of the following criteria: Diabetes mellitus. Thyroid dysfunction. Concomitant cardiovascular disorders. Respiratory, renal and liver dysfunction. Tubal adhesions as well as uterine abnormalities.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    MANAL Ahmed El Shafei Mohamed, Lecturer
    Phone
    201220664518
    Email
    Manalpt1989@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Mohamed Abdel Hamid El gaedy, Master
    Phone
    +20 109 943 0782
    Email
    dr.mohamed_elgaedy@yahoo.com

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    From may 2021 to may 2022

    Learn more about this trial

    Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs

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