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

Mohamed Abdel Hamid elgaedy

Status

Unknown

Conditions

Polycystic Ovary Syndrome

Treatments

Device: Electro acupuncture in group B

Device: Ultrasound cavitation in group A

Study type

Interventional

Funder types

Other

Identifiers

NCT04875312

012/003187

Details and patient eligibility

About

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

Full 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

Enrollment

40 estimated patients

Sex

Female

Ages

20 to 35 years old

Volunteers

Accepts Healthy Volunteers

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