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
About this trial
This is an interventional treatment trial for Polycystic Ovary Syndrome
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.
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
NCT ID
NCT04875312
First Posted
April 19, 2021
Last Updated
May 5, 2021
Sponsor
Mohamed Abdel Hamid elgaedy
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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