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

NCT07143682 | Completed Phase 3

• 1 other identifier: 4286
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Polycystic Ovarian Syndrome (PCOS); Infertility

Keywords

Polycystic ovary syndrome; letrozole; ovulation induction

Outcome Measures

Primary Outcomes (2)

• The number of participants having mature follicle (mean diameter ≥18mm)

  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)

  The number of participants having adequate endometrial thickness ( 7mm or more) on the day of trigger

  3 months

Secondary Outcomes (1)

• Pregnancy

  4 months

Study Arms (2)

Letrozole step up

EXPERIMENTAL

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

Conventional fixed dose letrozole

ACTIVE COMPARATOR

Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle

Drug: Conventional fixed dose letrozole

Interventions

Letrozol step up dose DRUG

Tablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days

Letrozole step up

Conventional fixed dose letrozole DRUG

Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle

Conventional fixed dose letrozole

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• PCOS women with subfertility
• Selected for ovulation induction

You may not qualify if:

• 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

Sponsors & Collaborators

• Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh: lead

Study Sites (1)

Bangabandhu Sheikh Mujib Medical University

Dhaka, 1200, Bangladesh

Location

Related Publications (1)

• Kaur J, Suri V, Gainder S, Arora A. Prospective randomized trial comparing efficacy of letrozole step-up protocol with letrozole plus gonadotropins for controlled ovarian stimulation and intrauterine insemination in patients with unexplained infertility. Arch Gynecol Obstet. 2019 Dec;300(6):1767-1771. doi: 10.1007/s00404-019-05326-2. Epub 2019 Oct 20.

  PMID: 31631248 BACKGROUND

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Infertility

Interventions

Congresses as Topic; Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Organizations; Health Care Economics and Organizations; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Shakeela Ishrat

Study Record Dates

• First Submitted: August 20, 2025
• First Posted: August 27, 2025
• Study Start: January 8, 2023
• Primary Completion: May 24, 2024
• Study Completion: June 30, 2024
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)