Clinical trial NCT04875312: Effect of UC Versus EA on Sex Hormones in Obese Infertile Patients With PCOs
Official title: Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-05-06
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: weight
timeFrame: up to 12 weeks
measure: waist/hip ratio:
timeFrame: up to 12 weeks
measure: Testosterone hormones :
timeFrame: up to 12 weeks
measure: FSH Hormone
timeFrame: up to 12 weeks
measure: Lh hormones
timeFrame: up to 12 weeks
measure: Progesterone hormones
timeFrame: up to 12 weeks
measure: Height
timeFrame: up to 12 weeks
Secondary outcomes:
measure: Ovulation rate
timeFrame: up to 12 weeks
Other outcomes:
Locations:
Study officials:
References: