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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Polycystic Ovary Syndrome
• Intervention / Treatment: Device: Ultrasound cavitation in group A; Device: Electro acupuncture in group B

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:

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

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MANAL Ahmed El Shafei Mohamed, Lecturer; Phone Number: 201220664518; Email: Manalpt1989@gmail.com
• Study Contact Backup: Name: Mohamed Abdel Hamid El gaedy, Master; Phone Number: +20 109 943 0782; Email: dr.mohamed_elgaedy@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group USC; Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome	Device: Ultrasound cavitation in group A; 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)
Experimental: Group EA; Effect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome	Device: Electro acupuncture in group B; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
weight	It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.	up to 12 weeks
waist/hip ratio:	It will be use tape measurement to calculate the waist/hip ratio.	up to 12 weeks
Testosterone hormones :	They will be use kites for assessment of level of testosterone hormones	up to 12 weeks
FSH Hormone	They will be use kites for assessment of level of FSH hormones	up to 12 weeks
Lh hormones	They will be use kites for assessment of level of LH hormones	up to 12 weeks
Progesterone hormones	They will be use kites for assessment of level of progesterone hormones	up to 12 weeks
Height	It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.	up to 12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ovulation rate	It will be use ultrasonography for measuring ovulation rate.	up to 12 weeks

Collaborators and Investigators

• Sponsor: Mohamed Abdel Hamid elgaedy

Study record dates

Study Major Dates

• Study Start (Anticipated): April 30, 2021
• Primary Completion (Anticipated): July 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 4, 2021
• First Posted (Actual): May 6, 2021

Study Record Updates

• Last Update Posted (Actual): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: 012/003187

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: From may 2021 to may 2022
• IPD Sharing Supporting Information Type: Study Protocol; Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No