It was randomised controlled study to compare the efficacy of clomiphene and letrozole in polycystic ovarian syndrome(PCOS) women with infertility.The aim was to select more appropriate treatment for ovulation induction in PCOS women.
The prevalence of infertility due to polycystic ovarian syndrome in Pakistan is 21.9%.It leads to an ovulation which results in infertility.The objective of this study was to compare the efficacy of letrozole vs clomiphene citrate for ovulation induction in PCOS women.Methods.It was a randomised controlled trial conducted in department of gynaecology and obstetrics ,Services Hospital Lahore from 2016-2019. Total 230 patients were included in study, they were divided in two groups, out of which 220 patients were analysed. .Group-A patients were given clomiphene citrate 50-150mg per day for 5 days starting from 2nd day of menses and group B patients were given letrozole 2.5-7.5mg per day for 5 days. Transvaginal ultrasound monitoring done from day 10-12 of menstrual cycle to measure follicle number and size.When follicle achieved a diameter of 18-20mm, then Inj HCG(human chorionic gonadotropin)10,000 IU intramuscular was given. Ovulation was confirmed by day 21 S.progesterone. When patient conceived, they were followed up till delivery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
220
Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.
Services Institute of Medical sciences
Lahore, Punjab Province, Pakistan
Pregnancy rate
Total number of patients conceived after treatment
Time frame: 5th week of cycle when periods missed
ovulation rate
when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
Time frame: 10-22 day of cycle
Live birth rate
total number of live births divided by total number of patients in a group
Time frame: 9 months
Monofollicular development
when only one follicle achieve diameter of greater than or equal to 18mm
Time frame: 10-12 day of menstrual cycle
Multifollicular development
when 2 or more follicles achieve diameter of \>12mm
Time frame: 10-12 day of menstrual cycle
Miscarraige
spontaneous loss of pregnancy before 24 weeks of gestation
Time frame: Less than 24weeks
Adverse effects
hot flushes.
Time frame: first 10days of cycle
Adverse effects
Fatigue and dizziness
Time frame: first 10days of cycle
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