Infertility, Polycystic Ovary Syndrome
Conditions
Keywords
polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole
Brief summary
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.
Detailed description
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.
Interventions
DRUGletrozole 2.5mg-7.5mg
Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
DRUGClomiphene Citrate 50mg-150mg
Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.
Sponsors
Services Institute of Medical Sciences, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Two treatment groups were made by random computer generated number i.e. Group A and Group B. Two Concealed boxes labelling A and B containing study drugs were made by pharmacist.Then participants were given drug from concealed boxes according to computer generated number.
Intervention model description
Total 230 patients were randomized in study, divided in two groups by computer generated numbers, out of which 220 patients were analyzed. .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.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* Women age between 18-40 years. * Normal husband semen analysis.
Exclusion criteria
* All infertile couples who had other causes of infertility than PCOS. * Those who had recently taken these medications. * Any contraindication to use of drugs e.g renal or hepatic dysfunction, hypersensitivity to this drug. * BMI\>35 because obese women respond poorly to ovulation induction.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pregnancy rate | 5th week of cycle when periods missed | Total number of patients conceived after treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Live birth rate | 9 months | total number of live births divided by total number of patients in a group |
| Monofollicular development | 10-12 day of menstrual cycle | when only one follicle achieve diameter of greater than or equal to 18mm |
| ovulation rate | 10-22 day of cycle | when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone. |
| Miscarraige | Less than 24weeks | spontaneous loss of pregnancy before 24 weeks of gestation |
| Adverse effects | first 10days of cycle | hot flushes. |
| Multifollicular development | 10-12 day of menstrual cycle | when 2 or more follicles achieve diameter of \>12mm |
Countries
Pakistan
Outcome results
None listed