Effect of Ultrasound Cavitation Versus Electro Acupuncture on Sex Hormones in Obese Infertile Patients With Polycystic Ovarian Syndrome
Phase: NA
Conditions: Polycystic Ovary Syndrome
Sponsor: Mohamed Abdel Hamid elgaedy

1 
 
Ethical comitee number approval: 012/003187 
       Document Date: February 22, 2021 
 
EFFECT  OF ULTRASOUND CAVITATION VERSUS 
ELCTROACUPUNCTURE ON SEX HORMONES IN 
OBESE INFERTILE PATIENTS WITH POLY CYSTIC 
OVARIAN SYNDROME 
 
 
 
 
By 
Mohamed Abdel Hamid ElGaedy 
 
 
 
 
 
Protocol submitted in Partial Fulfillment for the requirements 
of the Master Degree in Physical Therapy 
Department for Women Health 
 
 
 
Faculty of Physical Therapy 
Cairo University 
 
2021 

2 
 
Supervisors 
 
 
 
 
Prof. Dr. Mohamed Ahmed  Mohamed Awad 
Professor of Physical Therapy for Women's Health 
      Faculty of Physical Therapy 
Cairo University 
 
 
 
Dr. Seddiq Mohamed El Saied El Boray 
     Consultant of Obstetrics and Gynecology 
Aga Central Hospital 
 
 
 
Dr. Manal Ahmed El Shafei Mohamed  
Lecturer of Physical Therapy for Women's Health     
Faculty of Physical Therapy 
      Cairo University 
 
 

3 
 
 CHAPTER I 
INTRODUCTION            
Polycystic ovary syndrome (PCOS) is a common endocrine and 
metabolic disorder that occurs in 6 – 10% of women at the reproductive 
age (March et al., 2010).  It is associated with an-ovulation, infertility, 
hyperandrogenism, obesity and insulin resistance (Williams et al., 2016). 
Endocrine 
characteristics 
of 
PCOS 
are 
elevated 
serum 
concentrations of androgens and Luteinizing hormone (LH) and 
decreased concentrations of sex hormone binding globulin (SHBG). The 
an-ovulation is associated with disturbance in the feedback from ovarian 
steroid hormones to the hypothalamus and pituitary, resulting in 
disturbances of the pulsatility of gonadotropin releasing hormone (GnRH) 
(Williams et al., 2016).  
 Ultrasound cavitation (UC) (also known as fat cavitation or  lipo- 
cavitation) is the method in handling Subcutaneous Adipose Tissue 
(SAT), 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 (Palumbo 
et al., 2011).  
 The suitable parameter of the UC is 20-70 kHz ultrasound energy 
that will be emitted at certain depth in a convergent way and focused at a 
certain point to produce unlimited small vacuum bubbles (fat bubbling). 
These bubbles are compressed to break the bonds among fat cells, and 
destroy their membranes to form " cavitation’s" (holes in the fat layer) 
then drain them via lymphatic vessels to be excreted from the body 
(Brown et al., 2009).  

4 
 
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 and fasting insulin 
(Hanan et al., 2011). 
  
Acupuncture is a treatment method used in Traditional Chinese 
Medicine (TCM). It has been used for treatment of neurological and 
musculoskeletal diseases such as intervertebral disk disease and spinal 
cord injury (To and Wong, 2003) . 
In electro-acupuncture, the therapist inserts the acupuncture 
needles in acupuncture points and electric current is connected to the 
body through the acupuncture needles (Ahsin et al., 2009). The 
stimulation can be measured more objectively and regulated more 
precisely through adjustments of the electrical current, amplitude and 
frequency.  Electro-acupuncture can produce a higher and more 
continuous level of stimulation than manual manipulation; this is 
especially useful in acupuncture anesthesia.  In addition, it is possible to 
apply the current through an electrode on the skin surface, without the aid 
of a needle inserted subcutaneously (Steven and William, 2007).          
Electroacupuncture promotes follicle development and corrects 
reproductive endocrine dysfunction in ovaries by regulating the functions 
of the hypothalamus, pituitary and ovaries (Johansson et al., 2013). 
Statement of the problem : 
Is there is any difference between the effect of Ultrasound 
Cavitation and Elctroacupuncture on sex hormones in obese infertile 
patients with poly cystic ovarian syndrome? 
 

5 
 
Purpose of the study : 
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. 
 Significance of the study : 
PCOS is the most common endocrine abnormality in reproductive-
age women. The prevalence of  PCOS is traditionally estimated at 4% to 
8% from studies performed in Greece, Spain and the USA (Arslanian   et 
al., 2000).  
PCOS is the most common cause of an ovulatory infertility. It 
accounts for 90% to 95% of women attending infertility clinics with 
anovulation. However 60% of women with PCOS are fertile (defined as 
the ability to conceive within 12 months), although time to conceive is 
often increased.  In those with PCOS and infertility, 90% are overweight. 
Obesity independently exacerbates infertility, reduces efficacy of 
infertility treatment and induces a greater risk of miscarriage (Brassard  
et al., 2008). 
There is currently an active debate about the appropriate limit for 
body mass index for assisted reproduction therapies, given the reduced 
success rates and the demonstrated risks of pregnancy in overweight 
women. Ideally, weight should be optimized prior to pregnancy. Age-
related infertility also exacerbates infertility and timely planning of 
families may warrant discussion (Cedergren, 2007). 
Cavitation ultrasound is supposed to correct the negative impacts 
of abdominal adipose tissues on the ovarian function and clinical 
manifestations in women with PCOS and abdominal obesity (Ascher, 
2010).  

6 
 
Many studies reported the efficacy and safety of cavitation in 
reducing visceral adipose tissues and abdominal subcutaneous tissue, and 
they showed that there is a great decrease in fat thickness of subcutaneous 
tissue within the treated area and there is consistent reduction in 
abdominal circumference >2 cm after a single treatment (Jewell et al., 
2012 and Saedi et al., 2013). 
Regarding the effect of electroacupuncture on infertile patient with 
PCO, previous clinical trials suggest that acupuncture may induce 
ovulation, improve menstrual frequency and improve depression, anxiety, 
and health-related quality of life in PCOS patients (Stener-Victorin et 
al., 2013 and Zheng et al., 2013). In addition, electroacupuncture is able 
to decrease abnormally high levels of circulating luteinizing hormone 
(LH), which affect the LH/follicle-stimulating hormone (FSH) ratio and 
high levels of testosterone (Jedel et al., 2011). 
Till now, there are no previous studies that compare between the 
effect of ultrasound cavitation and electroacupuncture on sex hormones in 
obese infertile patients with PCO. So, this studies will be the first one in  
this issue. Therefore, this study will be of valuable benefits for medical 
services organizations and increase body of knowledge of physical 
therapists in scientific field. 
Delimitations: 
This study will be delimited to: 
1- Forty obese infertile patients with poly cystic ovarian syndrome. 
2- Their ages will be ranged between 20-35 year old. 
3- Their body mass index will be ranged from 30-40 kg/m2. 
4- All of them are married women. 
 

7 
 
Limitations: 
         This study will be limited to the following criteria : 
1- Psychological status. 
2- Cooperation of the patients may affect the result of the study. 
3- Environmental factors which may have affected the patient's 
response. 
4- The daily effort may affect the result of the study. 
Null Hypothesis: 
         It will be hypothesized that, there is no difference between the 
effect of ultrasound cavitation and electroacupuncture on sex hormones in 
obese infertile patients with  poly cystic ovarian syndrome.  
Basic assumptions: 
        It will be assumed that: 
1- All patients will show adequate cooperation with study procedure . 
2- All patients will follow the instructions that will be given to them. 
3- Clinical methods of evaluation will be reliable and valid. 
4- Results obtained from this study will be of value in physical 
therapy. 
 
 
 
 
 
 

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                                 CHAPTER II 
                        LITERATURE REVIEW 
PCOS is the major endocrine disorder affecting females in age of 
reproduction and is considered to be the most common cause of an 
ovulatory infertility. According to diagnostic criteria, PCOS affects 12-
21% of women in child bearing period of life; however, many cases are 
undiagnosed (Stabile et al., 2014). It represents a condition in which an 
estimate of 10 small cysts of a diameter ranging between 2 and 9 mm 
develop on one or both ovaries and/or the ovarian volume in at least one 
ovary exceeds 10 ml (Balen and Rajkowha, 2003). 
Although it was previously considered as a disorder of adult 
women, recent evidence suggests that PCOS is a lifelong syndrome, 
manifesting since prenatal age. In fact, according to the Rotterdam 
diagnostic criteria, the prevalence of  PCOS, in adolescents varies 
between a minimum of 3% (Hashemipour et al., 2004) and a maximum 
of 26% (Driscoll, 2003). However, the prevalence of the disease in 
children is still considered unknown (Kamangar et al., 2015). 
The economic burden of PCOS is significantly huge. Around 4 
billion dollars are spent annually in the United States to screen for the 
disease and treat its various morbidities, including hirsutism, infertility, 
and diabetes mellitus. The Australian Health System spends more than 
800 million dollars every year to account for the disease (Azziz et al., 
2005). Therefore, accurate and early diagnosis of  PCOS is necessary not 
only to prevent future health comorbidities but also to reduce financial 
cost and burden (Kamangar et al., 2015). 
  
 

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Obesity and PCO 
The prevalence of obesity reaches 80% in the United States and 
50% outside which indicates that this figure depends on local 
environmental factors, ethnic backgrounds, and lifestyle, and not on the 
mere presence of  PCOS itself. On the other hand, women with  PCOS  
are at a higher risk of developing obesity (Balen et al., 1995 and 
Randeva et al., 2012). 
 
Many studies explain that females with PCOS have increased 
visceral and subcutaneous body fat distribution due to increased androgen 
production rates; this central obesity follows a masculinized body fat 
distribution where the amount of visceral fat correlates with the degree of 
insulin resistance (Karabulut et al., 2012 and Borruel et al., 2013). 
         Obese women with PCOS have a characteristic distribution of a 
central pattern of body fat known as android obesity in which fat 
deposited in the abdominal wall and visceral mesenteric area. This fat is 
more sensitive to catechol-amines and less sensitive to insulin (Pasquali 
and Casimirri, 2003).  In addition, women with higher waist/hip ratios 
(i.e. more abdominal relative to hip fat) have higher total androgen and 
lower SHBG levels (Pasquali et al., 1997). 
 Moreover, obesity plays a significant role in expressing the 
metabolic features of  PCOS. Women with PCOS have an atherogenic 
lipid profile, associated with elevated levels of low-density lipoprotein, 
triglycerides and cholesterol, along with decreased levels of high-density 
lipoprotein. They are also at a higher risk of developing atherosclerosis, 
arterial stiffness, and altered vascular endothelium (Hart and Norman, 
2006).  In addition, women with PCOS show a worsened cardiovascular 
profile and associated complications (Randeva et al., 2012) . 

10 
 
However, obesity by itself is not the main reason behind these 
features. This is evident in lean women with PCOS who demonstrate the 
same metabolic features as those who are obese (Balen et al., 1995). 
Whether obesity leads to PCOS or whether PCOS leads to obesity is still 
debatable (Kamangar et al., 2015) . 
Obesity is also seen and associated with insulin resistance and 
decreased SHBG as well as, in many cases, increased testosterone 
concentrations (Velazquez, 2006). Thus, obesity appears to be strongly 
related to affect the activity of hypothalamic-pituitary axis which causes 
excessive LH concentrations resulting in a lower chance of conception 
(Regan et al., 2005). 
Infertility and PCO: 
Women with  PCOS may have reduced fertility due to the 
associated endocrine and gynecologic abnormalities that impact ovarian 
quality and function (Hart and Norman, 2006). Accounting for up to 
90% of ovulatory disorders,  PCOS associated persistent periods of 
anovulation are positively correlated with infertility (Imani et al., 1998). 
In 1995, a study reported up to 50 and 25% of women in a PCOS 
population suffering from primary and secondary infertility respectively 
(Balen et al., 1995). On the other hand, some studies suggested that 
females with PCOS who conceive might suffer from pregnancy-related 
complications 
such 
as 
gestational 
diabetes, 
pregnancy 
induced 
hypertension and preeclampsia to a higher extent in comparison to 
matched controls (Sir-Petermann et al., 2012; Bruyneel et al., 2014 
and Katulski et al., 2015). 
Various research data also suggest an increased risk of miscarriage 
in women with PCOS (Winter et al., 2002). Concerning the effects on 

11 
 
the embryo, women with PCOS are 2.5 times at a higher risk of giving 
birth to small for gestational age children in comparison to healthy 
females (Katulski et al., 2015) and offspring show an increased 
morbidity and mortality compared to control (Fauser et al., 2012). 
Various methods used in the treatment of PCO: 
Therapeutic strategies in PCOS include diet-induced weight loss, 
exercise and medical therapy fail to optimally treat PCOS and all of these 
can reduce but not reverse IR (Sabbour et al., 2009). 
1- Hypocaloric diet : 
         Standard dietary management of obesity and related comorbidities 
is a nutritionally adequate, low fat (approximately 30% of energy, 
saturated fat approximately 10%), moderate protein (approximately 15%) 
and high carbohydrate intake (approximately 55%), with increased fiber-
rich wholegrain breads, cereals, fruits and vegetables and moderate 
regular exercise. A moderate energy reduction diet (500 to 1,000 kcal/day 
reduction) reduces body weight by 7% to 10% over a period of 6 to 12 
months (Dansinger  et al., 2005). 
2- Life style modification: 
        Lifestyle change is first line treatment in an evidence-based 
approach in the management of the majority of PCOS women who are 
overweight (Moran et al., 2009). 
        Furthermore, prevention of excess weight gain should be 
emphasized in all women with PCOS of both normal or increased body 
weight. As little as 5% to 10% weight loss has significant clinical benefits 
improving psychological outcomes, reproductive features (menstrual 
cyclist, ovulation and fertility) and metabolic features (insulin resistance 
and risk factors for CVD and DM2) (Galletly et al., 1996). Evidence 

12 
 
shows that lifestyle change with small achievable goals results in clinical 
benefits even when women remain in the overweight or obese range 
(Wahrenberg et al., 1999). 
3- Exercise:  
        Incorporating simple moderate physical activity including structured 
exercise (at least 30 min/day) and incidental exercise increases weight 
loss and improves clinical outcomes in PCOS compared to diet alone. 
Exercise alone also improves clinical outcomes (Poehlman et al., 2000). 
       Aerobic exercise for 12 weeks is an effective method to decrease 
visceral fat, waist circumference, in obese subjects with T2DM even 
without weight loss. Frequent aerobic exercise has been shown to 
increase HDL-C levels by approximately 5% as early as 2 months from 
start of regular exercise in sedentary but otherwise healthy individuals 
(Dekker et al., 2007).                                                                             
   
                            
4- Medical treatment: 
A- Oral contraceptive pills (OCP): 
OCP are the most commonly used medications for the long-term 
treatment of women with  PCO and have been recommended by the Task 
Force and the Endocrine Society (Legro et al., 2013), the Australian 
Alliance (Misso et al., 2014) and the PCOS Consensus Group as first-line 
treatment for hyperandrogenism and menstrual cycle irregularities in 
women with PCOS (Fauser et al., 2012). 
         By suppressing the hypothalamic-pituitary-ovarian axis, OCP 
decrease LH secretions, increase sex hormone binding globulins, and 
decrease free testosterone levels. This addresses hyperandrogenism-
mediated symptoms improving acne and hirsutism, corrects menstrual 

13 
 
cycle abnormalities and provides a mean for effective contraception 
(Costello et al., 2007). 
Even though guidelines do not specify the use of one OCP over 
another and the best choice for symptomatic treatment is considered to be 
low-dose oral contraceptives that contain anti-androgenic or neutral 
progestin (Fauser et al., 2012 and Legro et al., 2013). 
A number of clinical trials encouraged the use of  OCP in patients 
with PCOS with increased risk of insulin resistance (Baillargeon et al., 
2003 and Legro et al., 2013). Concerns have been also raised about the 
negative effects of OCP on the cardiovascular profile of females with 
PCOS (Baillargeon et al., 2005). 
B- Metformin: 
Metformin (Glucophage), an oral anti-diabetic biguanide drug, acts 
by impeding hepatic glucose production and increasing the peripheral 
insulin sensitivity (Bailey and Turner, 1996). Some data revealed that 
metformin does not improve insulin resistance itself, rather it improves 
glucose effectiveness, i.e., the ability of glucose per se to repress 
endogenous glucose synthesis and stimulate glucose uptake (Pau et al., 
2014). 
Metformin treatment of obese adolescents with PCOS and 
impaired glucose tolerance proved beneficial in improving glucose 
tolerance and insulin sensitivity, in lowering insulinemia and in reducing 
elevated androgen levels (Arslanian et al., 2002) . 
Even though studies show contradictory results regarding 
metformin effect, it is suggested as first-line treatment for cutaneous 
manifestations and pregnancy complications in women with PCOS. It is 
also used as a combination with clomiphene citrate to improve fertility 

14 
 
outcomes in clomiphene citrate resistant patients (Legro et al., 2013 and 
Misso et al., 2014). 
5- Ultrasound cavitation : 
Ultrasound Fat Cavitation (USFC) is the method in handling 
obesity, especially in destroying fat and shaping a particular part of the 
body. As one of the non-surgical correction methods, USFC is preferred 
at decreasing the risk of complications due to obesity (Palumbo et al., 
2011).  
The cavitation used in the field of aesthetic medicine is an 
innovative technique for a nonsurgical reduction of the localized fat and 
cellulite, Ultrasonic vibrations spread in the form of a wave in medium 
such as a liquid or a solid. When the particles of an elastic medium are 
under ultrasonic vibration, they act continuously in only one direction 
(Sabbour et al., 2009).  
This phenomenon called cavitation is a very smart way to reduce 
fat because it is converting the fat into liquid and then is naturally 
eliminated with the urine when cavitation therapy is followed by 
lymphatic drainage. The process is faster and the drainage is very 
effective (Ter-Haar  and Coussios, 2007).  
Studies have proven that ultrasound is characterized as a safe, 
noninvasive, reliable and predictable ways for body sculpting (Palumbo 
et al., 2011).  Despite that, a lot studies claim to produce statistically 
significant results, the clinical benefits of ultrasound have yet to be 
approved (Ascher, 2010). This reduction in regional fat distribution could 
contribute to the effect of cavitation in improving the hormonal profiles 
(higher rates of ovulation, higher rate of regular menstrual cycles, lower 

15 
 
levels of LH/FSH Ratio and total testosterone) in obese women with 
PCOS (Hanan et al., 2011). 
6- Electroacupuncture : 
           Acupuncture has been the subject of active scientific research 
since the late 20th century but it remains controversial among medical 
researchers and clinicians. It is able to decrease abnormally high levels of 
circulating luteinizing hormone (LH), which affect the LH/follicle-
stimulating hormone (FSH) ratio and high levels of testosterone (Ernst et 
al., 2007). 
Point selection, location and application : 
There are tender areas at certain points of the body surface with all 
diseases, regardless of whether they are physical or mental, which 
disappear when the illness is cured.  There are called acupuncture points. 
Jayasuria (1993), stated that the use of acupuncture points to treat 
diseases of local and adjacent areas is one of the key principles in the 
practice of acupuncture therapy. It is the first consideration that should 
govern the selection of the acupuncture points for any regional disease. 
The local points are the most effective points in treating a majority of 
disorders. Every acupuncture point has a local effect on the surrounding 
tissues (Stux and Pomeranz, 1998) . 
Location methods for body acupuncture : 
There are various methods for locating acupuncture points (Focks, 
2008) :  
Anatomical approach: many acupuncture points are situated at 
clearly defined anatomical locations, for example in depressions, at 
muscle and tendon insertions, in grooves, at joint clefts, at bony 
prominences, etc. 

16 
 
Proportional measurements: when trying to locate points not 
situated at any prominent structures, Chinese medicine applies the 
proportional cun measurement. 
Electric tools: these measure the electric resistance of the skin in 
order to find the correct location of the points. Generally, electric 
resistance is lower in the immediate area around the point. 
   Sex hormones changes: 
a- Testosterone: 
- A total testosterone is likely to be more reliable than a free 
testosterone given the difficulties seen with many of the assays used 
for the latter (Rosner, 2001). 
- Testosterone values may be normal in PCOS. - Oral contraceptives 
will lower total testosterone, and interpretation in this setting is 
difficult (3 months off oral contraceptives is best to get a “true” 
testosterone value). 
- Most testosterone values in PCOS will be 200 ng/dL (> 6.9 nmol/L) 
warrant consideration of an ovarian or adrenal tumor (Derksen et al., 
1994) . 
b- Luteinizing Hormone/Follicular Stimulating Hormone: 
- Luteinizing hormone/follicle stimulating hormone (LH/FSH) ratio - A 
ratio >2.0 is suggestive of  PCOS but is not highly sensitive or specific 
(Fritz MA and Speroff  L, 2011).  
c- serum progesterone level: 
-   If mid-luteal serum progesterone level will be elevated above 6 ng/ml,                    
it will lead to confirm ovulation (Ellaithy, 2012). 
 

17 
 
                                    CHAPTER III 
             SUBJECTS, MATERIALS AND METHODS 
Study Design: 
This study will be designed as prospective, randomized, single blind, 
experimental, pre-post test , controlled- trial study. 
 
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 on the following 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. 
 
All patients will be divided randomly into two equal groups (A&B). 

18 
 
Group A:  
It will consist of twenty obese infertile patients with PCO who will be 
treated by ultrasound cavitation  on the abdomen, 2 times per week for  3 
months  with medical treatment in addition to hypocaloric diet (1200 
kcal/day) for 3 months.   
Group B: 
 It will consist of twenty obese infertile patients with PCO who will be 
treated by electroacupuncture, 3 times per week for  3 months  with 
medical treatment in addition to hypocaloric diet (1200 kcal/day) for 3 
months. 
 All patients will be given a full explanation of the study protocol and 
consent form will be signed by each woman before participating in the 
study, the purpose  and nature of the study will be explained to all 
patients (Appendix I). 
II- 
Instrumentations: 
1- Recording data sheet (Appendix II). 
2- Standard weight height scale: 
It will be used to measure weight and height to calculate the body 
mass index (BMI) for each woman. 
3- Tape measurement:  
It will be used to calculate the waist/hip ratio. 
4- Test tubes: 
Sterilized test tubes will be used to collect the blood samples from 
obese infertile patients with PCO. 
 
 
5- Kites: 

19 
 
They will be used for assessment of serum progesterone level, 
testosterone, LH and FSH hormones. 
6- Abdominal ultrasongraphy: 
     It will be used for measuring ovulation rate. 
7- Focused ultrasound cavitation:  
Fat cavitation, biCAVI (Ultimate). It will be  used to apply the 
treatment procedure for all patients in group A . 
8- Electro acupuncture: 
     It will be used to apply the treatment procedure for all patients in       
group B.            
III- Procedures: 
A- Evaluative procedures: 
1. Weight and height measurements: 
     Weight and height measurements will be measured while the patient is 
     wearing a thin layer of clothes to calculate the BMI according to the   
following equation before and after treatment for both groups (A&B): 
 
    
 
     BMI = weight/height2 (kg/m2).  
2. Waist and Hip Ratio: 
 -   It must be taken in order to accurately measure obesity rather than just 
visually inspecting of naked body (reference of female measurements
   
 
: minimal waist circumference >88 cm and waist-hip ratio >0.85).  
- It is measured by tape, waist Circumference will be measured at the 
narrowest portion of the torso approximately midway between the 
lower costal margin and the iliac crest and the hip circumference will 
be measured over the widest portion of the gluteal and greater 
trochanteric region then the ratio between them will be calculated. 

20 
 
3. Blood analysis: 
Blood samples will be drown from antecubital vein of each patient 
before and after treatment. It will be centrifuged within 2 hours after 
withdrawal. Serum is stared at -20 oC and assayed for LH/ FSH Ratio,  
Testosterone and Luteal Serum Progesterone. They will be measured 
from 3th day from menstrual cycle (Richard et al.,  2010 and 
Ellaithy, 2012).  
4. Ovulation rate: 
- It will be done before and after treatment for patients in both groups 
through luteal serum progesterone assay . 
- The number of patients who had evidence of successful ovulation 
during the 3 months.  
- Ovulation will be confirmed by the elevation of serum progesterone 
level. 
B- Treatment procedures : 
1- Medical treatment: 
Both group (A&B) will follow the same medical treatment as prescribed 
by gynecologist. 
2- Hpocaloric diet: 
Both group (A&B) will follow the same hypocaloric diet as prescribed by 
nutrition specialist (1200kcal per day). 
3- Ultrasound cavitation: 
- Each patient  in group A will be treated by  ultrasound cavitation, two 
sessions per week for 3 months. 

21 
 
-  Before starting treatment session, each patient will be instructed to 
evacuate her bladder to make sure that she is comfortable and relaxed 
throughout the treatment session. 
- From standing position, the abdominal area of each patient will be 
divided transversally into 3 parts; Part I: from the xiphoid process to 3 
cm above the umbilicus, Part II: from 3cm above the umbilicus to 2 
cm below the umbilicus and Part III: from 2 cm below the umbilicus 
to the pubic bone, and vertically each part was divided into right and 
left segments in relation to the linea alba, forming a total of 6 
abdominal segments. 
- Skin of the anterior abdominal wall will be cleaned with alcohol then, 
a conducting medium (gel) will be applied to the cavitational head of 
the ultrasound device, the device will be turned on, the program of 
cavitation; frequency (40 kHz) will be chosen, the time will be 
adjusted at 30 minutes and the intensity will be adjusted at 50% in the 
first 6 sessions while it will be adjusted at 75% at the last 6 sessions . 
- Then the cavitational head will be moved very slowly on each 
abdominal segment in a small circular movement for 5 minutes.  
- After finishing the focused ultrasound of the 6 segments of the 
abdomen, the skin will be cleaned with cotton. The total duration of 
the ultrasound treatment session on the 6 segments of the abdominal 
area will be 30 minutes. 
4- Electroacupuncture: 
- Each patient  in group B will be treated by  electroacupuncture, three 
sessions per week for 3 months. 
- The electrodes must be applied on the effective acupuncture points in 
somatic segments that innervates the ovary and uterus (Th12-L2 and 
S2-4). 

22 
 
- Electric stimulation with low frequency 2Hz, pulse width 0.5ms for 
30minutes will be chosen. 
Statistical analysis : 
Data will be collected and statistically analyzed using: 
- Descriptive statistics including mean and stander deviation. 
- Unpaired t-test will be conducted for comparison of mean values of 
pre and post-treatment between groups. 
- Paired t-test will be conducted for comparison  between pre and post-
treatment mean values in each group. 
- Level of significance, the degree of significance will be selected at 
5%, P value <0.05 will indicate non-significant results, P value > 0.05 
will indicate a highly significant result. 
 
 
 
 
 
 
 
 
 
 

23 
 
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. 
 
 

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Appendix I 
Informed consent form 
I am Misses /                                                  freely and voluntarily 
consent to participate in research study under the direction of the 
researcher /Mohamed  Abdel Hamid  Elgaedy .  A through description of 
the procedures has been explained and I understand that I may withdraw 
my consent and discontinue participation in this research at any time 
without prejudice to me. 
Participant:                                                                                    Date: 
……………………….                                                   …………………..                          
 
 
 
 
 
 
 
 
 
 
 

33 
 
Appendix II 
Recording data sheet 
 
Number: 
Name: 
Group: 
Age: 
Address: 
Occupation: 
 
 
 
 
Group  
 
Before treatment 
 
After treatment 
     Weight 
 
 
     Height 
 
 
     BMI 
 
 
  Waist/Hip Ratio    
Hi R i
 
 
  Testosterone 
 
 
LH/FSH Ratio 
 
 
Progesterone 
 
 
 
 
 

34