Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Letrozole vs Clomiphene Citrate for Induction of Ovulation in Women With Polycystic Ovarian Syndrome: Randomised Control Trial

Conditions
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Polycystic Ovary Syndrome, Infertility

Intervention / Treatment
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* Drug: letrozole 2.5mg-7.5mg
* Drug: Clomiphene Citrate 50mg-150mg


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: letrozole<br>Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses. | Drug: letrozole 2.5mg-7.5mg<br>* Tab letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.<br>* Other names: tab lezra 2.5-7.5mg;|
| Active Comparator: Clomiphene citrate<br>Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses. | Drug: Clomiphene Citrate 50mg-150mg<br>* Tab clomiphene citrate 50-150mg per day for 5 days started from 2nd day of menses.<br>* Other names: tab clomid 50-150mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy rate | Total number of patients conceived after treatment | 5th week of cycle when periods missed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ovulation rate | when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone. | 10-22 day of cycle | 
| Live birth rate | total number of live births divided by total number of patients in a group | 9 months | 
| Monofollicular development | when only one follicle achieve diameter of greater than or equal to 18mm | 10-12 day of menstrual cycle | 
| Multifollicular development | when 2 or more follicles achieve diameter of >12mm | 10-12 day of menstrual cycle | 
| Miscarraige | spontaneous loss of pregnancy before 24 weeks of gestation | Less than 24weeks | 
| Adverse effects | hot flushes. | first 10days of cycle | 
| Adverse effects | Fatigue and dizziness | first 10days of cycle | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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polycystic ovary syndrome, Infertility, Clomiphene citrate, Letrozole