Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
NCT07143682 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 70
Last updated 2025-12-16
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
Interventions
- 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
- DRUG
-
Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Sponsors & Collaborators
-
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 35 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-01-08
- Primary Completion
- 2024-05-24
- Completion
- 2024-06-30
Countries
- Bangladesh
Study Locations
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