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

Phase 2

Completed

• Conditions: Polycystic Ovary Syndrome; Infertility
• Interventions: Drug: letrozole 2.5mg-7.5mg; Drug: Clomiphene Citrate 50mg-150mg

• Registration Number: NCT05702957
• Lead Sponsor: Services Institute of Medical Sciences, Pakistan

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.

Study Timeline

• Study Start: 2016-09
• Primary Completion: 2019-10
• Study Completion: 2019-12
• Study First Submitted: 2022-12-08
• Status Verified: 2023-01
• Study First Submitted QC: 2023-01-18
• Last Update Submitted: 2023-01-18
• Study First Posted: 2023-01-27
• Last Update Posted: 2023-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
letrozole	letrozole 2.5mg-7.5mg	Patients were given letrozole 2.5 mg-7.5mg per day for 5 days started from 2nd day of menses.
Clomiphene citrate	Clomiphene Citrate 50mg-150mg	Patients were given clomiphene citrate 50-150mg per day for 5 days started from 2nd day of the menses.

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	5th week of cycle when periods missed	Total number of patients conceived after treatment

Secondary Outcome Measures

Name	Time	Method
ovulation rate	10-22 day of cycle	when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
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
Multifollicular development	10-12 day of menstrual cycle	when 2 or more follicles achieve diameter of \>12mm
Miscarraige	Less than 24weeks	spontaneous loss of pregnancy before 24 weeks of gestation
Adverse effects	first 10days of cycle	Fatigue and dizziness

Trial Locations

Locations (1)

Services Institute of Medical sciences; 🇵🇰 Lahore, Punjab, Pakistan