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

Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh

Status and phase: Completed; Phase 3

Conditions: Infertility; Polycystic Ovarian Syndrome (PCOS)

Treatments: Drug: Letrozol step up dose; Drug: Conventional fixed dose letrozole

Study type: Interventional

Funder types: Other

Identifiers

NCT07143682

4286

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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70 participants in 2 patient groups

Letrozole step up

Experimental group

Description:

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

Treatment:

Drug: Letrozol step up dose

Conventional fixed dose letrozole

Active Comparator group

Description:

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

Treatment:

Drug: Conventional fixed dose letrozole