Letrozole 5 mg for 10 Days Versus Letrozole 10 mg for 5 Days for Ovarian Stimulation in PCOS

NCT07448272 | Active Not Recruiting

• 1 other identifier: 5671
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

PCOS (Polycystic Ovary Syndrome)

Keywords

PCOS; OID

Outcome Measures

Primary Outcomes (2)

• • Presence of preovulatory follicle

  Preovulatory follicle:A follicle14 mm or more

  12 weeks

• Multifollicular development

  Multifollicular development: Presence of more than one preovulatory follicle

  12 weeks

Secondary Outcomes (4)

• Number of developing follicles

  3 months

• Days to LH surge

  3 months

• Ovulation rate

  3 months

• Pregnancy rate

  3 months

Study Arms (2)

Experimental arm: Letrozole 5mg 10 days

EXPERIMENTAL

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

Comparator arm

ACTIVE COMPARATOR

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

Interventions

Tab letrozole 5mg for 10 days DRUG

Tab letrozole 5mg for 10 days from day 2-3 ofenstruation/withdrawal bleeding (5mg at bed time for 10 days) for three months.

Experimental arm: Letrozole 5mg 10 days

Tabletrozole 10mg for 5 days DRUG

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

Comparator arm

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Mst.Sumyara Khatun: lead
• Bangladesh Medical University: collaborator

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

• Guo Z, Chen S, Chen Z, Hu P, Hao Y, Yu Q. Predictors of response to ovulation induction using letrozole in women with polycystic ovary syndrome. BMC Endocr Disord. 2023 Apr 25;23(1):90. doi: 10.1186/s12902-023-01336-z.

  PMID: 37098539 RESULT

• Franik S, Kremer JA, Nelen WL, Farquhar C. Aromatase inhibitors for subfertile women with polycystic ovary syndrome. Cochrane Database Syst Rev. 2014 Feb 24;(2):CD010287. doi: 10.1002/14651858.CD010287.pub2.

  PMID: 24563180 RESULT

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Letrozole

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Shakeela Ishrat

  Bangladesh Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: March 4, 2026
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)