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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875312
• Other study ID #: 012/003187
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2021
• Est. completion date: August 1, 2021

Study information

• Verified date: May 2021
• Source: Cairo University
• Contact: MANAL Ahmed El Shafei Mohamed, Lecturer
• Phone: 201220664518
• Email: Manalpt1989[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome
• Syndrome

Intervention

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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mohamed Abdel Hamid elgaedy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight	It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.	up to 12 weeks
Primary	waist/hip ratio:	It will be use tape measurement to calculate the waist/hip ratio.	up to 12 weeks
Primary	Testosterone hormones :	They will be use kites for assessment of level of testosterone hormones	up to 12 weeks
Primary	FSH Hormone	They will be use kites for assessment of level of FSH hormones	up to 12 weeks
Primary	Lh hormones	They will be use kites for assessment of level of LH hormones	up to 12 weeks
Primary	Progesterone hormones	They will be use kites for assessment of level of progesterone hormones	up to 12 weeks
Primary	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	Ovulation rate	It will be use ultrasonography for measuring ovulation rate.	up to 12 weeks