Letrozole Step up Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
Letrozole Step up Compared to Conventional Protocol for Ovulation Induction in Infertile Women With Polycystic Ovary Syndrome
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Dhaka, Bangladesh, 1200
- Bangabandhu Sheikh Mujib Medical University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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
|
Tablet letrozole 2.5mg one, two, three, and four tablets once daily from 2nd/3rd day of the menstrual cycle for 4 days
|
|
Active Comparator: Conventional fixed dose letrozole
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
|
Tab letrozole 5mg once daily for 5 days started from the 2nd/3rd day of the menstrual cycle
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
3 months
|
|
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
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pregnancy
Time Frame: 4 months
|
4 months
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Endocrine System Diseases
- Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Genital Diseases, Female
- Ovarian Diseases
- Adnexal Diseases
- Gonadal Disorders
- Ovarian Cysts
- Cysts
- Polycystic Ovary Syndrome
- Infertility
- Organic Chemicals
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Azoles
- Organizations
- Health Care Economics and Organizations
- Nitriles
- Triazoles
- Letrozole
- Congresses as Topic
Other Study ID Numbers
- 4286
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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