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Could a higher dose of letrozole unlock fertility for women with PCOS?

NCT ID NCT07759518

Disease control Sponsor: Mst.Sumyara Khatun Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 12, 2026 · Last updated Aug 13, 2026 · Updated 1 time

Summary

This trial is testing whether a higher dose of the fertility drug letrozole (10 mg) works better than the standard lower dose (5 mg) for stimulating ovulation in infertile women with polycystic ovary syndrome (PCOS). About 86 women aged 18-35 with PCOS will take one of the two doses for five days each cycle, for up to three months. Researchers will track follicle growth, ovulation, and pregnancy rates to see if the higher dose improves outcomes without increasing side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
letrozole (an aromatase inhibitor used to stimulate ovulation)
What this could lead to
If the higher dose works better, it could offer a more effective oral option for women with PCOS struggling to conceive, potentially improving ovulation and pregnancy rates.
What could go wrong
This is a small, early-stage trial, and the higher dose may not prove more effective or could increase side effects. Results may not apply to all women with PCOS.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

86 people

The number who actually took part.

Started

Feb 2025

Finished

Feb 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 35 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Age: 18-35 years old 2. BMI : 18-30 kg/m2 3. Diagnosed cases of PCOS patients according to Rotterdam criteria. 4. Corrected hypothyroidism and hyperprolactinemia Exclusion criteria: 1. Women with other infertility factors (endometriosis, tubal and uterine causes of infertility) 2. Male factor infertility 3. Impaired hepatic or renal function 4. History of hypersensitivity to letrozole \- \-

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Conditions

The condition(s) this trial relates to.

polycystic ovary syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

PCOS

Contacts and locations

Locations

  • Bangladesh Medical University

    Dhaka, 1000, Bangladesh

More trials for these conditions

Other studies related to the condition(s) this trial covers.