Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
NCT ID: NCT07143682
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
70 participants
INTERVENTIONAL
2023-01-08
2024-06-30
Brief Summary
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* 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
Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
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
Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Interventions
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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
Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Eligibility Criteria
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Inclusion Criteria
* Selected for ovulation induction
Exclusion Criteria
* Women with other infertility factors (endometriosis, suspected tubal factor, and uterine causes of infertility)
* Male factor infertility
18 Years
35 Years
FEMALE
No
Sponsors
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Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
OTHER
Responsible Party
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Shakeela Ishrat
Professor Shakeela Ishrat
Locations
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Bangabandhu Sheikh Mujib Medical University
Dhaka, , Bangladesh
Countries
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References
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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.
Other Identifiers
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4286
Identifier Type: -
Identifier Source: org_study_id