NCT07759518

Brief Summary

The goal of this clinical trial is to learn if drug letrozole 10mg for 5 days works better than letrozole 5mg 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 10mg for 5 days works better than letrozole 5 mg for 5 days for ovarian stimulation in infertile women with PCOS Participants will: The experimental arm (p1) will be treated with letrozole 10 mg for 5 days. The comparator arm (p2) will receive letrozole 5 mg 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 around day 10 of menstrual cycle

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2026

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 year

First QC Date

August 3, 2026

Last Update Submit

August 6, 2026

Conditions

PCOS

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)

  • Ovulation Rate

    3 months

  • Pregnancy rate

    3 months

  • Number of developing follicles

    3 months

  • Days to LH surge

    3 months

Study Arms (2)

Tab.Letrozole 10 mg for 5 days

EXPERIMENTAL

Tab letrozole 10 mg for 5 days from day 2-3 of menstruation/withdrawal bleeding (5mg at morning and 5mg bed time for 5 days) for 3 cycle

Drug: Tab.Letrozole 10 mg for 5 days

Tab.Letrozole 5 mg for 5 days

ACTIVE COMPARATOR

Tab letrozole 5mg for 5 days from day 2-3 of enstruation/withdrawal bleeding ( 5mg at bed time for 5 days) for three cycle

Drug: Tab.Letrozole 5mg for 5 days

Interventions

Tab.Letrozole 10 mg for 5 daysDRUG

Tablet 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 months

Tab.Letrozole 10 mg for 5 days
Tab.Letrozole 5mg for 5 daysDRUG

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

Tab.Letrozole 5 mg for 5 days

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age: 18-35 years old
  • BMI : 18-30 kg/m2
  • Diagnosed cases of PCOS patients according to Rotterdam criteria.
  • Corrected hypothyroidism and hyperprolactinemia

You may not qualify if:

  • Women with other infertility factors (endometriosis, tubal and uterine causes of infertility)
  • Male factor infertility
  • Impaired hepatic or renal function
  • History of hypersensitivity to letrozole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangladesh Medical University

Dhaka, 1000, Bangladesh

Location

Related Publications (2)

  • Mandelbaum RS, Agarwal R, Melville S, Violette CJ, Winer S, Shoupe D, Matsuo K, Paulson RJ, Quinn MM. A comparison of letrozole regimens for ovulation induction in women with polycystic ovary syndrome. F S Rep. 2024 Mar 28;5(2):170-175. doi: 10.1016/j.xfre.2024.03.004. eCollection 2024 Jun.

    PMID: 38983726RESULT

  • Ramezanzadeh F, Nasiri R, Sarafraz Yazdi M, Baghrei M. A randomized trial of ovulation induction with two different doses of Letrozole in women with PCOS. Arch Gynecol Obstet. 2011 Oct;284(4):1029-34. doi: 10.1007/s00404-011-1951-5. Epub 2011 Jul 7.

    PMID: 21735192RESULT

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

August 3, 2026

First Posted

August 12, 2026

Study Start

February 1, 2025

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Locations

BA(1)