Ridzuan, Jamaludin
(2008)
Prospective randomized control trial comparing
metformin and clomiphine citrate as ovulation
induction agent in women with polycystic ovarian
syndrome at Alor Star Hospital, Malaysia.
Masters thesis, Universiti Sains Malaysia.
Abstract
To evaluate the effects of metformin on weight reduction , waist hip ratio , menstrual
cycle and ovulation rates among women with polycystic ovarian syndrome with infertility
taking metformin alone , clomiphene citrate alone and combination of metformin and
clomiphene citrate. 115 patients diagnosed to have polycystic ovarian syndrome (according to the revised
Rotterdam ESHRE/ASRM criteria, 2003) attending Infertility Clinic of Alar Star were
recruited into the study and later randomized into three group i.e. Group A (metformin
alone, n=38), Group 8 (CC alone, n=39) and Group C (combination of metformin and
CC, n=38). During initial visit, the WHR were measured. Baseline investigations were
taken which include follicular stimulating hormone, luteinising hormone, testosterone,
liver function test, renal function test and serum prolactin. In Group A, metfromin 500mg
tds were given up to 6 months. Clomiphene citrate 1 OOmg daily was given from the
second until the sixth day of menstruation for those patients in Group B. The dosage
was increased by 50mg for each cycle should anovulation was noted, to a maximur11 of
200mg. In Group C, a combination of metformin and clomiphene citrate were given and
the dosage were similar to Group A and B. For all three groups, ovulation was confirmed
by performing transvaginal scan. The WHR , serum follicular stimulating hormone ,
luteinising hormone and testosterone was repeated every three months. Metformin has no effects on weight reduction or waist hip ratio. 36.8% (14 out of 38
patients) and 57.9% (22 out of 38 patients) had spontaneous resumption of metformin ,
which might not due to the sole effect of metformin. Only 9 out of 38 patients (23.7%)
taking metformin alone had ovulation compared to 28 out of 39 patients (71.8%) who
take clomiphene citrate. This difference was significant statistically (p= 0.000). There
was no difference in the number of patients having ovulation between those taking
clomiphene citrate alone and combination of clomiphene citrate and metformin (28 out of
39 patients, 71 .8% and 26 out of 38 patients, 68.4% respectively; p= 0.470). Metformin has no effect on weight and waist hip ratio reduction. It should not be used to
regulate menstrual cycle in PCOS patients. Its usage was no superior than the
traditionally used clomphene citrate to bring ovulation among patients of polycystic
ovarian syndrome with fertility problem . No additional advantage could be gained if it is
combined with clomiphene citrate. Therefore, the current protocol to induce ovulation
among polycystic ovarian syndrome with infertility patients with clomiphene citrate alone
as the first line drug should remain.
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