Comparison of effect of Clomiphene citrate alone and Clomiphene citrate plus Metforminin Polycystic ovary syndrome patients : 1 Comparison of effect of Clomiphene citrate alone and Clomiphene citrate plus Metforminin Polycystic ovary syndrome patients By
07 -PML – 010
Department of Advanced Zoology and Biotechnology,
Loyola College, Chennai INTRODUCTION : 2 INTRODUCTION Polycystic (literally, many cysts) ovary syndrome (PCOS) is an endocrine disorder and a complex condition that affects the ovaries.
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. Slide 3: 3 What are the differentiating features of PCOS? Treatment aim is to improve: : 4 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 ovulation
Metformin to improve hyperinsulinemia
Most researches showed that addition of metformin to CC regulated menstrual cycles & pregnancies. What kindled my interest on this topic?? : 5 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 factors in 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. by IUI and Natural method. Materials & Methods : Materials & Methods Elecsys 2010 uses electrochemiluminescence immuno-assay (ECLIA) for the estimation 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 of polycystic ovarian syndrome and to monitor the follicle maturity.
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 p<0.05 it is significant and if p>0.05 it is insignificant. 6 RESULTS : RESULTS In 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 were assigned 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 Results contd….. : 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 & 8.8 mIU/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. 8 Results contd…. : Results contd…. 9 The overall effect of treatment on Prolactin level Results contd…... : Results contd…... 10 Discussion : 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 turn induces 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 Discussion contd…. : Discussion contd…. So I suggest that the effect of Clomiphene citrate may differ by the race, climatic conditions and the physiological changes that occur in 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<.05 and the treatment is effective, the treatment leads to hyperprolactinemia that interfere with pregnancy. 12 Discussion contd…. : 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 13 : To detect the exact mechanism of clomiphene citrate on the elevation of prolactin and the relation between the low pregnancy rate and hyperrprolactinemia
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 and othe 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 14 Future Perspectives Slide 15: 15 Thank You