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Comparison of effect of
Clomiphene citrate alone and
Clomiphene citrate plus Metformin
in Polycystic ovary syndrome patients
By
Krishna Kumari.S.
07 -PML 010
Department of Advanced Zoology and Biotechnology,
Loyola College, Chennai
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INTRODUCTIONPolycystic (literally, many cysts) ovary
syndrome (PCOS) is an endocrine disorder
and a complex condition that affects theovaries.
This disorder is characterized by changes to
the ovaries such that multiple follicles
accumulate in the ovaries without ovulation.
These follicles remain immature, never
growing to full development or ovulating to
produce an egg capable of being fertilized.
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What are the differentiating features of PCOS?
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Treatment aim is to improve:
Fertility, via the stimulation of ovulation.
Reduction of the insulin resistance.
Two major drugs used worldwide are
Clomiphene Citrate to induce ovulationMetformin to improve hyperinsulinemia
Most researches showed that addition of
metformin to CC regulated menstrual cycles &
pregnancies.
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What kindled my interest on this topic??
In general population nearly 25% of women have polycystic ovaries
Till now no clear evidence study about the treatment effect of these
drugs on Chennai women
Very low pregnancy rate??
Aim & Objective of the Study
Estimating the blood glucose level, Leutinisng hormone, Prolactin, ovulation
induction and rate of success in pregnancy after treatment with either CC
alone or CC plus Metformin.
To compare the effect of CC alone and Metformin plus CC on the above factorsin polycystic ovary syndrome.
To determine the overall effect of treatment on the above factors in
polycystic ovary syndrome
To determine the rate of success in pregnancy through different methods i.e. byIUI and Natural method.
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Materials & Methods
Elecsys 2010 uses electrochemiluminescence immuno-assay (ECLIA) for theestimation of leutinising hormone and prolactin. Roche/Hitachi works uses Immunoturbidimetric assay for the estimation of
blood glucose.
Ultrasound scanning machine uses Pulse-echo principle for the diagnosis ofpolycystic ovarian syndrome and to monitor the follicle maturity.
Statistical Tool:
All the data are statistically analyzed by using the SPSS software The comparison of two groups of treatments i.e. CC plus Metformin and CC
alone are analyzed through Paired T-test
If the p0.05 it is insignificant.6
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RESULTSIn this study 100 PCOD patients were examined and out of these 100, 21 were found to have abnormal
blood glucose level. They were given clomiphene citrate plus metformin. These 21 patients wereassigned as Group I. Another 79 patients were given Clomiphene Citrate alone and were assigned as
Group II.
Blood glucose level of 10 patients was found to be high and 11 patients have low glucose before
treatment. After treatment with metformin the 10 patients were found to have normal glucose level
and by improving the diet the 11 patients with low blood glucose were found to be improved
17 patients of Group I & 57 patients of Group II were found to have irregular menstrual cycle but
after treatment with both the group of drugs the ovulation was induced in all the patients
7
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Results contd ..
Both the Group of drugs showed 19% pregnancy rate
Rate of success through natural method was high in group I (5%) whereas the rate of
success through IUI was more in group II (16%)
The mean LH level before treatment was found to be 8.9 mIU/ml for Group I & 8.8mIU/ml for Group II patients. After treatment the mean LH level was reduced to
5.7 mIU/ml for both the groups of patients
The mean level of prolactin was found to be 15.8 ng/dl for group I patients & about
18.9 ng/dl for group II patients. After treatment the mean prolactin level was found
to be increased to about 21.8 in group I & 28.8 in group II patients.
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Results contd.
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Leve l o f Pro lac t in before t(va lues in ng /ml )
1 9
47
23
11
L e s s t h a n
10 -20
2 0 - 3 0
M o r e t h an
Level of Prolactin after treat(values in ng/ml)
7
21
40
32
Less than 10
10 -20
20 - 30
More than 3
The overall effect oftreatment on Prolactin level
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Results contd...
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Success in Pregnancy(Values in Nos.)
315
1468
Pregnant Natural
Pregnant IUI
Non-Pregnant Natural
Non-Pregnant IUI
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Discussion
When the previous literatures was analyzed most researches support that
addition of metformin improves the treatment effect. In this study I found
that both the groups of treatment have similar effects on PCOS.
The treatment is effective in regulating the blood glucose level and also the
level of LH. It is also effective in ovulation induction.
But the treatment with both the groups of drugs leads to
hyperprolactinemia. Clomiphene citrate an antioestrogen stimulates the
synthesis of estrogen by blocking the estrogen receptors. This in turninduces the pituitary lactotropes to secrete Prolactin. This results in the
elevation of prolactin level. The amount elevated through this mechanism is
negligible. But in this study we found that the prolactin level is increased by
10 times. 11
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Discussion contd.
So I suggest that the effect of Clomiphene citrate may differ by
the race, climatic conditions and the physiological changes that occurin response to clomiphene citrate is different for the South- Indian
patients affected with polycystic ovary syndrome. It is also suggested
that, the elevation may due to stress since prolactin is a stress
hormone.
Most researches suggest that the success in pregnancy through these
treatment is between 20-25% which somehow coincide with our study
as the pregnancy rate is found to be 19%
Though the paired t-test result shows that p
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Discussion contd .
From this study I suggest that
There is no added benefits of metformin when it is used in combination
with clomiphene citrate
This treatment leads to hyperprolactinemia that might be the reason
for the low pregnancy rates
The treatment is effective in regulating the blood glucose level, level of
LH and also helps in ovulation induction
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To detect the exact mechanism of clomiphene citrate on the elevation of
prolactin and the relation between the low pregnancy rate andhyperrprolactinemia
To design a drug that may not elevate the prolactin but regulates the LH level,
induce the ovulation and increases the pregnancy rate.
To study whether the effect of Clomiphene citrate differs with race, age andothe physiological properties
To detect the risk & incidence of endometrial cancer due to this treatment on
PCOD patients.
To study whether these drugs have any effect on estradiol, FSH, DHA etc.,To detect the role of serum CA 125 and estradiol in PCOS
To detect the rate of ovarian hyper stimulation by these drugs
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Future Perspectives
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Thank You