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

January 18, 2023 updated by: Tayyiba Wasim, Services Institute of Medical Sciences, Pakistan

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan, 54000
        • Services Institute of Medical Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 5th week of cycle when periods missed
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
Time Frame: 10-22 day of cycle
when follicle achieved diameter of 18-20mm,HCG given,ovulation confirmed by day 21 progesterone.
10-22 day of cycle
Live birth rate
Time Frame: 9 months
total number of live births divided by total number of patients in a group
9 months
Monofollicular development
Time Frame: 10-12 day of menstrual cycle
when only one follicle achieve diameter of greater than or equal to 18mm
10-12 day of menstrual cycle
Multifollicular development
Time Frame: 10-12 day of menstrual cycle
when 2 or more follicles achieve diameter of >12mm
10-12 day of menstrual cycle
Miscarraige
Time Frame: Less than 24weeks
spontaneous loss of pregnancy before 24 weeks of gestation
Less than 24weeks
Adverse effects
Time Frame: first 10days of cycle
hot flushes.
first 10days of cycle
Adverse effects
Time Frame: first 10days of cycle
Fatigue and dizziness
first 10days of cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Services Institute of Medical Sciences, Pakistan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

October 1, 2019

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

December 8, 2022

First Submitted That Met QC Criteria

January 18, 2023

First Posted (Actual)

January 27, 2023

Study Record Updates

Last Update Posted (Actual)

January 27, 2023

Last Update Submitted That Met QC Criteria

January 18, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB/2015/209/SIMS

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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