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

Not Applicable

Completed

• Conditions: Polycystic Ovarian Syndrome (PCOS); Infertility
• Interventions: Drug: Letrozol step up dose; Drug: Conventional fixed dose letrozole

• Registration Number: NCT07143682
• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

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 results 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 menstral cycle for checkups and tests

* Keep a diary of any untoward symptoms

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-08
• Primary Completion: 2024-05-24
• Study Completion: 2024-06-30
• Status Verified: 2025-08
• Study First Submitted: 2025-08-20
• Study First Submitted QC: 2025-08-20
• Last Update Submitted: 2025-08-20
• Study First Posted: 2025-08-27
• Last Update Posted: 2025-08-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Letrozole step up	Letrozol step up dose	Tab letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
Conventional fixed dose letrozole	Conventional fixed dose letrozole	Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle

Primary Outcome Measures

Name	Time	Method
Preovulatory follicle (mean diameter ≥18mm)	3 months
Endometrial thickness ( 7mm or more)	3 months

Secondary Outcome Measures

Name	Time	Method
Pregnancy	4 months

Trial Locations

Locations (1)

Bangabandhu Sheikh Mujib Medical University; 🇧🇩 Dhaka, Dhaka Division, Bangladesh