Letrozole Step up Compared to Conventional Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- The number of participants having mature follicle (mean diameter ≥18mm)
Study Overview
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
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
Intervention: Conventional fixed dose letrozole (Drug)
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
Intervention: Letrozol step up dose (Drug)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
- Pregnancy(4 months)
Investigators
Shakeela Ishrat
Professor Shakeela Ishrat
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh