Ignite Creation Date:
2024-05-06 @ 4:07 PM
Last Modification Date:
2024-10-26 @ 2:04 PM
Study NCT ID:
NCT04875312
Status:
UNKNOWN
Last Update Posted:
2021-05-07
First Post:
2021-04-19
Brief Title:
Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs
Sponsor:
Mohamed Abdel Hamid elgaedy
Organization:
Cairo University
Study Overview
Official Title:
Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
Status:
UNKNOWN
Status Verified Date:
2021-05
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 AB
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 kcalday
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 kcalday II- Instrumentations
1 Recording data sheet Appendix II
2 Standard weight height scale measure BMI
3 Tape measurement measure waisthip ratio
4 Test tubes used to collect the blood samples from obese infertile patients
5 Kites used for assessment of serum progesterone level testosterone LH and FSH
6 Abdominal ultrasongraphy measure ovulation rate
7 cavitation in group A 8- electroacupuncture in group B
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 AB
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 kcalday
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 kcalday II- Instrumentations
1 Recording data sheet Appendix II
2 Standard weight height scale measure BMI
3 Tape measurement measure waisthip ratio
4 Test tubes used to collect the blood samples from obese infertile patients
5 Kites used for assessment of serum progesterone level testosterone LH and FSH
6 Abdominal ultrasongraphy measure ovulation rate
7 cavitation in group A 8- electroacupuncture in group B
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None