Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome

December 9, 2025 updated by: Shakeela Ishrat, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Letrozole Step up Compared to Conventional Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome

The goal of this clinical trial is to learn if drug letrozole in step up dose works better to treat anovulation in infertile women with polycystic ovary syndrome. It will also learn about the safety of drug letrozole in step up dose. The main Questions it aims to answer are:

  • Does drug letrozole in step up dose result in better ovarian response?
  • What medical problems do participants have when taking drug letrozole in step up dose? Researchers will compare drug letrozole step up dose to a standard low dose to see if the step up dose works to achieve better ovarian response.

Participants will:

  • Take drug letrozole step up or standard low dose from day 2 of menstruation for 3 cycles
  • Visit the clinic on day 12-16 of menstural cycle for checkups and tests
  • Keep a diary of any untoward symptoms

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Polycystic ovary syndrome (PCOS) is the largest single cause of anovulatory infertility. Letrozole, an aromatase inhibitor, has been regarded as the first-line drug for ovulation induction in PCOS patients. The conventional protocol of letrozole includes the administration of a fixed dose of letrozole (2.5 -7.5 mg) for 5 days. Few recent studies have shown that the step-up letrozole protocol causes more follicles to grow, induces more ovulation, and increases the pregnancy rate. This study aimed to compare the effect of the letrozole step-up and conventional fixed-dose protocol for ovulation induction in infertile women with PCOS.

Methods: This open-label randomized controlled study was conducted on a total of 70 infertile PCOS women eligible for ovulation induction. Treatment with letrozole started from day 2-3 of menstruation or withdrawal bleeding. They were randomly allocated into two groups. The experimental group (n=35) was given step-up letrozole, one (2.5 mg), two (5 mg), three (7.5 mg), and four (10 mg) tablets, single dose sequentially for 4 days. The comparator group (n=35) received conventional fixed-dose letrozole, two (5mg) tablets daily for 5 days. The outcome variables were the number of participants having a mature follicle by day 12-16 of the cycle and the number of mature follicles on the day of trigger.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • 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

  • Bangladesh
      • Dhaka, Bangladesh, 1200
        • Bangabandhu Sheikh Mujib Medical University

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • PCOS women with subfertility
  • Selected for ovulation induction

Exclusion Criteria:

  • Body mass index (BMI) ˂18 and ≥30 kg/m2,
  • Women with other infertility factors (endometriosis, suspected tubal factor, and uterine causes of infertility)
  • Male factor infertility

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Letrozole step up
Tab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
Drug: Letrozol step up dose
Tablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
Active Comparator: Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Drug: Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number of participants having mature follicle (mean diameter ≥18mm)
Time Frame: 3 months
The number of participants having mature follicle (mean diameter ≥18mm) on day 12 to 16 of the cycle
3 months
The number of participants having adequate endometrial thickness ( 7mm or more)
Time Frame: 3 months
The number of participants having adequate endometrial thickness ( 7mm or more) on the day of trigger
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Pregnancy
Time Frame: 4 months
4 months

Collaborators and Investigators

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

Sponsor

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 8, 2023

Primary Completion (Actual)

May 24, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

August 20, 2025

First Submitted That Met QC Criteria

August 20, 2025

First Posted (Estimated)

August 27, 2025

Study Record Updates

Last Update Posted (Actual)

December 16, 2025

Last Update Submitted That Met QC Criteria

December 9, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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