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临床试验/NCT04875312
NCT04875312Unknown不适用

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

Mohamed Abdel Hamid elgaedy0 个研究点目标入组 40 人开始时间: 2021年4月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
40
主要终点
Height

研究概览

简要总结

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

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Their ages will be ranged between 20-35 year old.
  • Their body mass index will be ranged from 30-40 kg/m
  • All of them are married women.

排除标准

  • Women will be excluded if they have one of the following criteria:
  • Diabetes mellitus.
  • Thyroid dysfunction.
  • Concomitant cardiovascular disorders.
  • Respiratory, renal and liver dysfunction.
  • Tubal adhesions as well as uterine abnormalities.

结局指标

主要结局

Height

时间窗: up to 12 weeks

It will be use tape measurement to measure height to calculate the body mass index (BMI) for each woman.

Testosterone hormones :

时间窗: up to 12 weeks

They will be use kites for assessment of level of testosterone hormones

Progesterone hormones

时间窗: up to 12 weeks

They will be use kites for assessment of level of progesterone hormones

FSH Hormone

时间窗: up to 12 weeks

They will be use kites for assessment of level of FSH hormones

Lh hormones

时间窗: up to 12 weeks

They will be use kites for assessment of level of LH hormones

weight

时间窗: up to 12 weeks

It will be use weight scale to measure weight to calculate the body mass index (BMI) for each woman.

waist/hip ratio:

时间窗: up to 12 weeks

It will be use tape measurement to calculate the waist/hip ratio.

次要结局

  • Ovulation rate(up to 12 weeks)

研究者

发起方
Mohamed Abdel Hamid elgaedy
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mohamed Abdel Hamid elgaedy

Head OF physical therapy in AGA hospital

Cairo University

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