POLYCYSTIC OVARIAN SYNDROME

A STUDY ON QOL AND EFFECT OF CoQ10 IN
POLYCYSTIC OVARIAN SYNDROME PATIENTS
MALLA REDDY COLLEGE OF PHARMACY
HEENA PARVEEN
Department of Pharmacology

CONTENTS:
 Introduction
 Backgroundinformation
 Aim& Objectives
 Reviewof literature
 Method
-Studysite
-Studydesign
-Samplesize
-Studyperiod
-Inclusioncriteria
-Exclusioncriteria
 Results& Discussion
 Conclusion
 Bibilography

INTRODUCTION :
 Polycystic ovarian syndrome is a disease characterized by
multiple[poly] cyst [small sacs filled with fluid] in the ovaries.
Patients with PCOS have abnormal levels of hormones that
results in irregular menses, infertility and certain masculine
changes in the body.

 The quality of life (QOL) is evaluated and showed that QOL
was worse in those with PCOS in the areas of general health
perception, behavior, physical function and family activity.
We wish to evaluate the psychometric properties of PCOS
patients with instrument i.e.; questionnaire (PCOSQ) - a
questionnaire developed to measure the QOL of women with
PCOS.
 Antioxidants are essential for protecting cells from damage in
PCOS patient.
 Co-Enzyme Q10 acts as antioxidant and reduces the oxidative
stress by increasing the production of cellular energy.
 CoQ-10 recylces vitamin-E & prevents its pro-oxidant
activity.It helps in ovulation induction.

BACKGROUND:
In 1935, the condition was first described by American
gynaecologists Irving F. Stein , Sr. and Michael Leventhal from
whom its original name of “STEIN-LEVENTHAL SYNDROME” is taken.
In 2003, the Rotterdam European Society for Human
Reproduction/American Society of Reproductive Medicine
(ESHRE/ASRM)– sponsored PCOS consensus workshop group
proposed that the diagnosis include two of the following three
criteria: oligo- and/or anovulation, clinical and/or biochemical
hyperandrogenism, and polycystic ovaries on ultrasound.

Medications
Medications to Regulate the
Menstrual Cycle
To regulate hormone levels and restore a
normal menstrual cycle in women with
PCOS.
 The birth control pill
 Medroxy Progesterone (Provera)
 Myo and d-chiro Inositol (Ovasitol)
 edications to Improve Insulin
Resistance
Typically known as diabetes medications,
insulin-sensitizers can reduce blood
glucose and insulin levels in people with
pre-diabetes, diabetes, or those at risk
for insulin resistance.
 Metformin
 Pioglitazone (Actos)
 Liraglutide (Saxenda, Victoza)
 Inositol Weight Loss Medications
 Sibutramine (Meridia)
 Orlistat (Xenical,Alli)
 Phentramine.
Medications
A variety of medications can be used to
improve egg quality, ovulation, and
fertility.
 Clomiphene citrate(Clomid, Fertomid)
 FSH (Gonal F, Follistim, Bravelle)
 HMG (Menopur)
 HCG
 Progesterone
 Estradiol(Estrace)
 Gonadotropins
 Inositol

Antioxidant
Antioxidant is a molecule capable of inhibiting the oxidation
of other molecules.
Oxidation reactions can form free radicals and these start
chain reactions that damage cells. Antioxidants terminate
these chain reactions by removing free radical
intermediates and inhibit other oxidation reactions.
They neutralize the substances that can damage the genetic
material by oxidation.

CoQ10
Coenzyme Q-10 (CoQ-10) --vitamin-like substance ,powerful Antioxidant naturally
found throughout the body, but especially in the heart, liver, kidney, and pancreas.
Alternate name “Ubiquinone” comes from the word Ubiquitous which means
“Found Everywhere”.
Chemical name: (2,3,-dimethoxy-5-methyl-6-decaprenil-1,4-benzoquinone).
 Coenzyme Q-10 is manufactured by fermenting beets and sugar cane with special
strains of yeast.
 Coenzyme Q-10 was first identified in 1957. The “Q-10” refers to the chemical make-
up of the substance (Isoprenyl Subunits). These days coenzyme Q-10 is used by
millions of people in Japan for heart disease, especially congestive heart failure.
 Coenzyme Q-10 might help increase energy. This is because CoQ-10 has a role in
producing ATP, a molecule in body cells that functions like a rechargeable battery in
the transfer of energy.

The reduced form of Coenzyme Q-10,also acts as an Anti-oxidant preventing
lipid peroxidation.
Co-enzymeQ-10 Capsules
Source Health kart(online)
Marketed by Bright Life care
Manufactured by Tirupati Life Sciences
M.R.P 1199.00
Capsules per bottle 60N
Dose 45 days
Dosage 100mg q .d (Once a day)
Route Oral

Steps in Biosynthesis
Biosynthesis occurs in most human tissue. There are three major steps:
 Creation of the benzoquinone structure (using phenylalanine or tyrosine)
 Creation of the isoprene side chain (using acetyl-CoA)
 The joining or condensation of the above two structures
The initial two reactions occur in mitochondria, the endoplasmic reticulum, and
peroxisomes, indicating multiple sites of synthesis in animal cells.
An important enzyme in this pathway is HMG-CoA reductase, usually a target for intervention in
cardiovascular complications.
The "statin" family of cholesterol-reducing medications inhibits HMG-CoA reductase.One possible side
effect of statins is decreased production of CoQ10, which may be connected to the development of
myopathy and rhabdomyolysis

Clinical Features
 Menstural abnormalities 90%
 Infertility Anovulation
 Hirsutism 60%,Acne 70%,Alopecia.
 Increased risk of Atherosclerosis & Cardiovascular events.
 Increased risk of Endometrial cancer & Breast cancer.
 Several mental health problems, Depression & Anxiety.
 Obesity 40% with increased risk of Osteoarthritis , Haemorrhoids, Hernias.

Criteria for
classification of
PCOS
Major Criteria Minor Criteria
Anovulation Polycystic
ovaries on
USG.
Oligomennorh
oea
Elevated
LH:FSH
Severe
Hirsutism
Acne
Hyperandrogen
aemia
Mild Hirsutism
Insulin
Resistance
Obesity
Tendency of PCOS: presence of one minor
criteria.
Mild form of PCOS: presence of two minor
criteria.
Moderate form of PCOS: presence of one major
& one minor criteria.
Severe form of PCOS: presence of one or more
major & two or more minor criteria.
Diagnosis

OBJECTIVES
I. To assess the quality of life.
II. To study effect of C0Q10 in PCOS.
III. Patients awareness on PCOS based on Age group.
IV. Awareness about the Diagnostic tests
V. Percentage response of participants towards the awareness of symptoms and
treatments available.
VI. Patients Response after treatment with Clomiphene citrate & CoQ10.
VII. Treatment outcomes in lean and obese PCOS patients treated with Clomiphene
citrate.
VIII.Treatment outcomes in lean and obese PCOS patients treated with CoQ10

NEED FOR THE STUDY:
Environmental factors such as diet or stress also can trigger
underlying risk factors and cause the development of
PCOS.
The complications of PCOS can be categorized into three
mechanisms:
(i) Hyperandrogenemia ,Ovarian volume ,No.of follicles.
Additional advantage of COQ10:
 COQ10 supplementation may also help reduce many
troublesome symptoms of menopause.
 COQ10 is useful for the treatment of people suffering from
Diabetes.
 COQ10 is essential component in the healthy
mitochondrial function

METHODOLOGY:
STUDY SITE:
The study was conducted in department of obstetrics and gynecology.
STUDY DESIGN:
Prospective comparative & interventonal study.
Follow up was carried out on the impact of patient education and effect of
anti -oxidant supplementation.
Data was collected after drug treatment through USG, Quesstionaires, Hormone
levels.
SAMPLE SIZE:
20 patients Standard & 20patients Drug treated.
STUDY PERIOD:
The study was carried out for the period of 9months.

INCLUSION CRITERIA:
 Age>18years and < 35 years
 Patients suffering with infertility associated with
PCOS.
 Patient suffering with Irregular menses.
EXCLUSION CRITERIA:
 Psychologically ill patients
 Patient who are not willing to participate in study.
 Patient suffering with Diabetes.
 Pregnant women.
 Women on Breast feeding.

Study procedure (Method):
PATIENT ENROLLMENT-
• Informed consent form.
• QOL Assessment.
• Supplementation of COQ10 in Anovulation & Irregular menses.
• Re-assessment of patient on following criteria:
i) QOL
ii) Improvement in - Anovulation ,Cycle irregularities
A hospital based Prospective interventional study was conducted on patients with newly diagnosed
Polycystic ovary syndrome in Gynaecology Department of the Malla Reddy Hospital, Suraram.
Statistical Analysis:
Data obtained was analysed by Student’s t-test. Differences were considered significant when P < 0.05.

PLANOFWORK:
Getting approval from medical superintendent of 3RTIARY hospital and
IHEC.
Collecting data in Proforma
Assessment of QOL
20 Patients are given with Clomiphene citrate
20 Patients are given with COQ10.

Assessment of quality of life before treatment & after 45 days treatment.
Estimated hormone levels(FSH,LH,E2) & No. of follicles
Statistical analysis of data
Results
Conclusion

Methodology
ESTIMATION OF FOLLICLE STIMULATING HORMONE
Dispense 50 μl standards and samples into their respective wells. Add 100 μl conjugate to each well. Leave
well A1 for substrate blank. Cover wells with the foil supplied in the kit.
Incubate for 1 hour at room temperature (22 – 28 °C).
When incubation has been completed, remove the foil, aspirate the content of the wells and wash
each well three times with 300 μl diluted wash solution.(Avoid overflows from the reaction
Wells.The soak time between each wash cycle should be >5sec).
At the end carefully remove remaining fluid by tapping strips on tissue paper prior to the next step.
Dispense 100 μl TMB Substrate Solution into all wells. Incubate for exactly 15 min at room temperature
(22 – 28°C) in the dark..
Dispense 100 μl Stop Solution into all wells in the same order and at the same rate as for the TMB Substrate
Solution.
Any blue color developed during the incubation turns into yellow. Measure the absorbance of the
specimen at 450 nm within 30 min after addition of the Stop Solution.
Measure the absorbance of all wells at 450 nm and record the absorbance values for each standard and
sample. Finally, FSH levels are estimated according to the sample range (mIU/ml).

The serum FSH values are comprised in the
following intervals:
SampleRangemIU/ml
• Male 1 – 4
• Female:
Follicular phase 3-12
Midcycle 8-22
Luteal phase 2-12
Menopausal 35-151

ESTIMATION OF LEUTINISING HORMONE:
Dispense 20 μl standards, control and samples into their respective wells. Add 100 μl
conjugate to each well.
Leave well A1 for substrate blank. Incubate for 1 hour at room temperature (22-28°C).
When incubation has been completed, aspirate the content of the wells and wash each well three
times with 300 μl diluted wash solution.
Avoid overflows from the reaction wells. At the end carefully remove remaining fluid by tapping
strips on tissue paper prior to the next step. Dispense 100 μl TMB Substrate Solution into
all wells.
Incubate for exactly 15 min at room temperature (22…28°C) in the dark. Dispense 100 μl Stop
Solution into all wells in the same order and at the same rate as for the TMB Substrate
Solution. Shake the microplate gently.
Any blue colour developed during the incubation turns into yellow. Measure the
absorbance of the specimen at 450 nm.

Sample Range mIU/ml
• Male 0.7-7.4
• Female:
• Follicular phase 0.5-10.5
• Ovulation phase mIU/ml 18.4-61.2
• Luteal phase mIU/ml 0.5-10.5
• Menopause 8.2 – 40.8
The serum LH values are comprised in the following
intervals:

Estimation of estradiol
Dispense 25 μl of standards, specimens and controls into appropriate wells.
Dispense 100 μl of Estradiol-HRP Conjugate Reagent into each well.
Dispense 50μl of rabbit anti-Estradiol (E2) reagent to each well. Thoroughly mix for 30 seconds.
It is very important to mix them completely. Incubate at room temperature (18-25°C) for 90
minutes. Rinse and flick the microwells 5 times with distilled or deionized water.
Dispense 100 μl of TMB Reagent into each well. Gently mix for 10 seconds. Incubate at room
temperature (18-25°C) for 20 minutes.
Stop the reaction by adding 100 μl of Stop Solution to each well. Gently mix 30 seconds.
It is important to make sure that all the blue color changes to yellow color
completely. Read absorbance at 450 nm with a microtiter well reader within 15 minutes.

The serum E2 values are comprised in the following
intervals:
MALE : < 60 pg/ml
FEMALES :
Postmenopausal phase < 18 pg/ml
Ovulating, early follicular 30-100 pg/ml
Late follicular 100-400 pg/ml
Luteal phase 60-150 pg/ml
Pregnant, normal up to 35,000 pg/ml
Prepubertal children < 10 pg/ml

Ferriman- Gallwey (mFG) scoring system
Upper lip
Chin
Chest
Upper back
Lower back
Upper abdomen
Lower abdomen
Upper arms
Thighs
In this scoring system, a total score of 18 is accepted as hirsutism.

Acanthosis scoring system
ABSENT(0)
Not detectable
on close
inspection
PRESENT(1)
Clearly present
on close visual
inspection,Not
to casual
observers.
MILD(2)
Limited to skull
base,doesn’t
extend to
lateral margins
of neck.
MODRATE(3)
Extends to
lateral margins
of neck but not
visible
anteriorly.
SEVERE(4)
Visible
anteriorly..
SEVERE(5)
Circumferential
.

Acanthosis Nigricans
Hair thinning at the top of the Head.

RESULTS
The sample size of this study was 40 patients.
Further,40 patients were distributed into 2 groups each.
20 patients into standard treatment & 20 patients into test treatment.

Table 1: Group wise distribution of patients
Groups No. of Patients (n=40)
Patients treated with standard
medicine
20
Patients treated with CoQ10 20
0
5
10
15
20
25
No.ofPatients
Standard Treatment Treatment with COQ10
Table 1:Group wise distribution of Patients
Illustrates 40 patients are divided in to two groups.20 are treated with normal regular
medicine and 20 patients are treated with CoQ10.

Marital status No. of Patients (n=40)
Married 30
Unmarried 10
Table 2:Distribution of patients based on marital status.
Table 2: Distribution of patients based on Marital status
Married Unmarried
Illustrates out of 40 Patients 30 patient are Married and 10 are Unmarried.
INFERENCE: From this we can observe that married females are more affected with PCOS
than unmarried females.

Table 3: Distribution of patients according to Age.
Age Group No. of Patients
18-20 8
21-23 13
24-26 7
27-29 7
30-32 3
33-35 2

0
2
4
6
8
10
12
14
18-20 21-23 24-26 27-29 30-32 33-35
No.ofPatients
Age group
Table 3: Age wise distribution of patients
Illustrates out of 80 patients 8 are between 18-20 years,13 are between 21-23 years,7 are between 24-26
years,7 are between 27-29 years,3 between 30-32 years,2 are between 33-35 years.
INFERENCE: From this we can observe that PCOS is more prevalent in age between 21-23 years.

Table 4: Distribution of patients based on major complaints
80%
20%
No.of Patients
Irregular menses Anovulation
Major complaints No of Patients (n=40)
Irregular menses 32
Anovulation 8
Illustrates out of 40 patients 32 are Irregular menses and 8 are Anovulation.
INFERENCE : From this we can observe that the major symptom of PCOS is causing Irregular
menses than Anovulation.

Table 5: Distribution of Patients according to Thyroid disease
Age of Patients Negative Positive
18-20 14 1
21-23 5 -
24-26 9 -
27-29 6 1
30-32 2 -
33-35 - 2

0
2
4
6
8
10
12
14
16
18-20 21-23 24-26 27-29 30-32 33-35
No.ofPatients
Age of Patients
Table 5: Distribution of patients according to Thyroid
disease
Negtaive
Positive
Illustrates out of 80 patients 36 are Negative 4 are Positive.
INFERENCE: TSH test indicates that whether the PCOS is caused due to hormonal changes or due to
abnormality in the Ovaries

Table6: Patients awareness on PCOS based on Age group
Participants Response(n=40) 18-22yrs
(n=17)
23-27 yrs
(n=12)
28-32 yrs
(n=9)
33& above yrs
(n=2)
% women tested with PCOS 13(32.5) 9(22.5) 3(7.5) 2(5)
% of women suffering with PCOS 10(25) 5(12.5) 2(5) 2(5)
%awareness about female infertlity 8(20) 3(7.5) 5(12.5) 2(5)
%regarding inclusion of PCOS 17(100) 12(100) 9(100) 2(100)
.

Illustrates percentage awareness of patients based on awareness about female infertility, women suffering with
PCOS, women tested with PCOS, opinion regarding inclusion of PCOS
0
5
10
15
20
25
30
35
40
45
18-22 23-27 28-32 33 & above
%ofwomen
Age group
Table 6:Awareness about female fertility,% of women suffering & tested
with PCOS & % opinion regarding inclusion of PCOS
% of women suffering with PCOS % women tested with PCOS
% awaeness about female infertility % opinion regarding inclusion of PCOS

0
5
10
15
20
25
30
35
40
Pelvic sound Sonography Laproscopic
examination
Diagnostic tests
Testing levels of
androgens in
serum
None of the
above
%ofwomen
Age group
18-22 yrs
23-27 yrs
28-32 yrs
33 & above yrs
Test type 18-22(n=17) 23-27(n=12) 28-32(n=9) 33 &above(n=2)
Pelvic sound 5(12.5) 1(2.5) 5(12.5) 2(5)
Songraphy 15(37.5) 9(22.5) 7(17.5) 2(5)
Laproscopic exam 1(2.5) 2(5) 1(2.5) 0(0)
Androgen levels in serum 9(22.5) 5(12.5) 6(15) 2(5)
None of the above 5(12.5) 6(15) 3(7.5) 0(0)
Table 7: Awareness about Diagnostic tests
Table 7: Awareness about Diagnostic tests
Illustrates response of participants towards the awareness of
diagnostic tests used for detection of PCOS.

Table 8: Percentage response of participants towards the awareness of symptoms and
treatments available
Age group 18-22yrs 23-27yrs 28-32yrs 33 & above yrs
Total 17 12 9 2
Symptoms % % % %
1 Menstural irregularities 88.2 75 87.5 100
2 Anovulation 47 25 55 -
3 Facial & Abdominal hair
growth
64.7 90 87.5 50
4 Weight gain 65.7 66.5 75 50
5 Pigmentation changes 41.1 74.6 25 100
6 Acne 88.2 58.3 62.5 100
7 Abdominal pain 94.1 75 85 100
Treatments % % % %
1 Oral contraceptives 23.5 50 55.5 100
2 Clomiphene citrate 17 16 11.1 0
3 Weight loss & diet adjustment 29.4 41.6 11.1 0

Table 9:Patient characteristics
Patient Characteristics COQ-10 n=(20) Clomiphene citrate n=(20)
Age 24.05±0.87 24.7±1.14
Parity 0.4±0.31 0.3±0.33
Clinical Presentation
Oligo/Anovualtion 8(40) 7(35)
Polycystic ovaries 19(95) 17(85)
Hyper-androgenism 16(80) 15(75)
Duration of infertility
(yrs)
2.50±1.511 2.37±1.685
Irregular menses 19(95) 17(85)
BMI 33.22±2.209 29.97 ± 1.207
LH 11.49±2.900 11.44±2.593
FSH 9.64±2.693 9.23±2.196
T3 0.61±0.661 1.18±1.319
T4 3.82±3.902 5.26±3.885
TSH 3.44±2.577 3.70±2.655

Table 10: Patients Response after treatment with Clomiphene citrate
& CoQ10
Values are mean ± SD or n(%).
Clomiphene citrate(n=20) CoQ10(n=20) P-Value
No.of follicles>14mm 5.65±0.58 10.70±0.79 0.0001
Endometrial thickness(mm) 5.55±0.5548 3.15±0.4661 0.02
Serum oestradiol 4.15±0.5345 15.25±1.015 0.0001
Clinical pregnancy per patient 1(5) 2(10) 0.001
0
2
4
6
8
10
12
14
16
No.of
follicles>14mm
No.of
follicles>18mm
Endometrial
thickness(mm)
Serum oestradiol Clinical pregnancy
per patient
Mean
PCOS Parametres
Patients Response after treatment with Clomiphene citrate & CoQ10
Clomiphene citrate(n=20)
CoQ10(n=20)

Table11: Treatment outcomes in lean and obese PCOS patients treated with
Clomiphene citrate.
Values are mean ± SD or n (%).
Lean PCOS(n=8) Obese PCOS(n=12) P-Value
Endometrial thickness(mm) 5.11±2.472 7.07±2.483 0.0001
Serum oestradiol 2.72±1.332 3.83±2.227 0.0001
Clinical pregnancy per patient 1(11.1) 0(0) 0.001

Table 12: Treatment outcomes in lean and obese PCOS patients treated with CoQ10
Lean PCOS(n=8) Obese PCOS(n=12) P-Value
Endometrial
thickness(mm)
6.87±1.667 6.93±2.068 0.0001
Serum oestradiol (pg/ml) 16.05±3.560 15.51±5.142 0.0001
Clinical pregnancy per
patient
1(12.5) 1(8.3) 0.0001
Values are mean ± SD or n (%).

We have demonstrated fromthisstudy that out of 40 participants,
62.5%of themwere aware about PCOS.
Awareness about PCOS was highest amongthe age group of 18-22
years.
PCOS is a common cause of an anovulation and femaleinfertility.
This study also showsthat very less number of women are aware
about the treatments whichare availablefor PCOS.
From, thisstudy it was observed that only 40%of women are aware
about the fact that long termPCOS condition can lead to infertility.
This study has showed that about 85%of women are sufferingwith
menstrual irregularities in PCOS women, and 40%are showing
anovulation.

• The number of follicles>14 mm and >18mm were significantlyhigher in the
CoQ10 group(P = 0.0001 and P =0.0001 respectively). Theendometrial thickness
was decreasedin the CoQ10group (5.55±0.5548mmversus 3.15±0.4661mm),
p=0.0020).Serumoestradiol was significantly higher in the CoQ-10 group
(4.15±0.535 versus 15.25±1.015,p=0.0001.In the CoQ10 group, clinical pregnancy
occurredin 2/20women(10%).
• In the CoQ10 group, the ovulationrate was 45%and the clinical pregnancyrate
was 10%.Of 12 womenwith obese PCOS, the ovulationrate was33.3% andthe
clinical pregnancyrate was 8.3%.Endometrial thickness was significantly
increased,p=0.0001 in women with obese PCOS versus leanPCOS. There was
statistical significant difference(i.e; increased) regardingnumber of
follicles>18mm,but serumoestradiol concentrations decreased.
• Whenthe control group was stratified into lean(9 women)whoseovulationrate
was 77.7%andin obese (11 women),ovulationrate was 36.36%,no statistically
significant differenceswerefoundin number of follicles,serumoestradiol and
endomertrial thickness was foundto be increasedin Obesepatients, clinical
pregnancy rates (11.1%versus0%).

Conclusion
CoQ10 is a mitochondrial antioxidant .It showedsignificant
effect over Clomiphene.
CoQ10 showedsignificant effect over irregular menses than
clomiphene citrate.
Co10 has showed the better results with in 45days of treatment
in irreguar menses & Anovulation whereas patient who were
using clomiphene since an year said there is a temporary effect
of the clomiphene.

CoQ10 was well tolerated by all the patients and no adverse
effects were observed. The lack of any statistically significant
differences in the follicles number between lean and obese
PCOS in the CoQ10 group suggest that response to CoQ10 is
independent of Body weight & Age.
Many of the patients complain that they are having temporary
effect of clomiphene as many of them were using medicines for
infertility & irregular menses for 6 months. If long term studies
with coq10 is performed it can be said that it may show the
permanent results of the pcos symptoms.

The results of this study are encouraging ; however the appropriate dosage of
CoQ-10 and the optimal duration of treatment needs to be further
investigated. Moreover, the effects of CoQ-10 therapy on hormonal and
metabolic profiles, the symptoms of hyperandrogenism and cardiovascular risk
factors need further assessment as to whether it is possible to modify these
risk factors, particularly in PCOS.
Future Prospective:
Many of the patients complain that they are having temporary effect of
clomiphene as many of them were using medicines for infertility & irregular
menses for 6 months.
If long term studies with coq10 is performed it can be said that it may show
the permanent cure of the pco symptoms.

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POLYCYSTIC OVARIAN SYNDROME

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