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

Polycystic Ovary Syndrome Clinical Trial

Official title: Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome

Status Not yet recruiting

Clinical Trial 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

Clinical Trial 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:

1. Recording data sheet (Appendix II).

2. Standard weight height scale: measure BMI

3. Tape measurement: measure waist/hip 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 ;

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

• NCT number: NCT04875312
• Study type: Interventional
• Source: Cairo University
• Contact: MANAL Ahmed El Shafei Mohamed, Lecturer
• Phone: 201220664518
• Email: Manalpt1989@gmail.com
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2021
• Completion date: August 1, 2021