Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS (PCOS OID)

March 2, 2026 updated by: Mst.Sumyara Khatun

Letrozole 5 mg for 10 Days Compared to Letrozole 10 mg for 5 Days for Ovarian Stimulation in Infertile Women With Polycystic Ovary Syndrome

The goal of this clinical trial is to learn if drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS. It will also learn about the safety of drug letrozole . The main questions it aims to answer are:

What medical problems do participants have when taking drug letrozole? Researchers will compare drug letrozole 5mg for 10 days works better than letrozole 10mg for 5 days for ovarian stimulation in infertile women with PCOS

Participants will:

The experimental arm (p1) will be treated with letrozole 5 mg for 10 days. The comparator arm (p2) will receive letrozole 10mg for 5 days for ovulation induction for consecutive 3 months Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.

Ovarian response will be assessed by trans-vaginal monitoring of follicle growth aroundday 8 and day 11of menstrual cycle

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

A total number of 80eligible PCOS women will be randomized to either letrozole 5mg for 10 days or letrozole 10mg for 5 days for ovulation induction. The experimental arm (p1) will be treated with letrozole 5 mg for 10 days. The comparator arm (p2) will receive letrozole 10mg for 5 days (Tab letrol 2.5mg -Renata Pharmaceutical. Treatment will start from the 2nd day of menstruation cycle or withdrawal bleeding after the baseline visit and investigations.

Ovarian response will be assessed by trans-vaginal monitoring of follicle growth aroundday 8 and day 11of menstrual cycle.The presence of preovulatory follicle, multifollicular development, the number of developingfollicles, size of largest follicle and endometrial thickness with pattern will be assessed. The woman will then be advised to test for LH surge by urinary LH kit daily until positive and when positive will have intercourse for two days. She will have serum progesterone estimation after 7 days. She will repeat same dose of ovulation induction if she has menstruationand if there are no symptoms of side effect regarding letrozole intake or will do pregnancy test if she misses period. If missed period occurs further visit will be required for serum β-hCG estimation for confirmation of pregnancy. If pregnancy test is positive she will do an USG for fetal cardiac motion around 7-8 weeks.If B-hCG negative I will give the woman Tab. Norethisterone (5mg) (Tab. Normens 5mg - Renata pharmaceuticals) for (7-10) days for withdrawal bleeding. After withdrawal bleeding I will give her previous dose letrozole. In that situation she will define as a case of anovulation. If cyst appears I will do a Transvaginal sonography of that woman in D2 of the cycle to observe the cyst. If cyst persist, I will hold stimulation in that cycle. If cyst disappear I will give stimulation. All subject will receive drugs (Tab. Letrol 2.5mg, Tab. Normens 5mg) from me. I will ensure their proper intake by cell phone and during their visit they will show their blank strip of drug for confirmation. The cumulative data will be subjected to analysis. by Statistical Package for Social Sciences version 27 for Windows (SPSS Inc., Chicago, Illinois, USA).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangladesh Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed cases of PCOS women according to Rotterdam criteria.
  • Age: 18-35 years old.
  • Primary or secondary infertility

Exclusion Criteria:

  • Women withother causes of anovulation (AsCushing syndrome, late onset congenital adrenal hyperplasia, uncorrected hypothyroidism, uncorrected hyperprolactinemia).
  • Women with other infertility factors like tubal and uterine causes of infertility, endometriosis, undiagnosed per vaginal bleeding (From history and examination).
  • History of hypersensitivity to letrozole.
  • BMI:< 18.5 kg/m2 and ≥30 kg/m2.
  • Male factor infertility.
  • Medical disease (uncontrolled HTN, uncontrolledDM, uncontrolledLiver disease, kidney disease).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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: Experimental arm: Letrozole 5mg 10 days
Tab letrozole 5mg for 10 days from day 2-3 of menstruation/withdrawal bleeding (5mg at bed time for 10 days) for 3 cycle
Drug: Tab letrozole 5mg for 10 days
Tab letrozole 5mg for 10 days from day 2-3 ofenstruation/withdrawal bleeding (5mg at bed time for 10 days) for three months.
Active Comparator: Comparator arm
Tab letrozole 10mg for 5 days from day 2-3 of enstruation/withdrawal bleeding (10mg in divided dose-5mg in morning & 5mg at bed time for 5 days) for three cycle
Drug: Tabletrozole 10mg for 5 days
Tabletrozole 10mg for 5 days from day 2-3 of enstruation/withdrawal bleeding (10mg in divided dose-5mg in morning & 5mg at bed time for 5 days) for three months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Presence of preovulatory follicle
Time Frame: 12 weeks
Preovulatory follicle:A follicle14 mm or more
12 weeks
Multifollicular development
Time Frame: 12 weeks
Multifollicular development: Presence of more than one preovulatory follicle
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of developing follicles
Time Frame: 3 months
Developing follicle:Follicles with mean diameter between 10-13 mm
3 months
Days to LH surge
Time Frame: 3 months
Days to LH surge: The number of days from the first dose of letrozole to LH surge determined by ovulation predictor kit.
3 months
Ovulation rate
Time Frame: 3 months

Ovulation:Ovulation will be diagnosed by presence of any one of following

  • Detecting LH surge in ovulation predictor kit
  • Day 21 progesterone level ≥ 3 ng/dl
  • An appropriately timed menses in previously oligomenorrheic patient
  • A positive pregnancy test
3 months
Pregnancy rate
Time Frame: 3 months
Pregnancy: Pregnancy will be determined after missed period by serum β-hCG estimation. Serum β-hCG> 5 mIU/mL is diagnosed as pregnancy [ Atellica integrated clinical chemistry and immunoassay analyzer] followed by the presence of fetal cardiac motion on ultrasound around 7-8wk
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mst.Sumyara Khatun

Collaborators

Bangladesh Medical University

Investigators

  • Study Director: Shakeela Ishrat, Bangladesh Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 4, 2026

Study Record Updates

Last Update Posted (Actual)

March 4, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5671

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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