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

NCT ID: NCT04875312

Last Updated: 2021-05-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-30
• Study Completion Date: 2021-08-01

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:

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

Conditions

Polycystic Ovary Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Group USC

Effect of ultrasound cavitation sessions on sex hormones in obese infertile patients with poly cystic ovarian syndrome

Group Type: EXPERIMENTAL

Ultrasound cavitation in group A

Intervention Type: DEVICE

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 EA

Effect of electro acupuncture on sex hormones in obese infertile patients with poly cystic ovarian syndrome

Group Type: EXPERIMENTAL

Electro acupuncture in group B

Intervention Type: DEVICE

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)

Interventions

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)

Intervention Type: 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)

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Mohamed Abdel Hamid elgaedy

OTHER

Sponsor Role: lead

Responsible Party

Mohamed Abdel Hamid elgaedy

Head OF physical therapy in AGA hospital

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

MANAL Ahmed El Shafei Mohamed, Lecturer

Role: CONTACT

Manalpt1989@gmail.com

201220664518

Mohamed Abdel Hamid El gaedy, Master

Role: CONTACT

dr.mohamed_elgaedy@yahoo.com

+20 109 943 0782

Provided Documents

Document Type: Study Protocol

View Document

Other Identifiers

012/003187

Identifier Type: -

Identifier Source: org_study_id