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New hope for PCOS: extended letrozole or adding inositol may help ovulation

NCT ID NCT07635082

Disease control Sponsor: Eman Basuni Ebrahim Mowad 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested two approaches to help women with PCOS who did not ovulate after standard letrozole treatment. One group took letrozole for 7 days instead of 5, and the other took letrozole plus inositol. The goal was to see which method led to more ovulations and pregnancies. The trial involved 200 women aged 18-35 with a BMI of 30 or less.

What this could mean

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

Active substance
letrozole and inositol
What this could lead to
If successful, this could offer a new treatment option for women with PCOS who do not respond to standard letrozole therapy, potentially improving ovulation and pregnancy rates.
What could go wrong
This is a small, completed phase 2 trial, so results may not apply to all PCOS patients. The interventions may not work for everyone, and there are risks like multiple pregnancy or ovarian hyperstimulation.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

200 people

The number who actually took part.

Started

Feb 2024

Finished

Jul 2025

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: * Women diagnosed with polycystic ovary syndrome (PCOS) according to the Rotterdam criteria. * Letrozole-resistant PCOS patients who failed to ovulate after receiving letrozole 5 mg daily for 5 days for three consecutive cycles. * Age 18 to 35 years. * Body mass index (BMI) ≤ 30 kg/m². * Normal uterine cavity and patent fallopian tubes confirmed by hysterosalpingography (HSG) and/or laparoscopy. * Partner with normal semen analysis. * Willing and able to provide informed consent. Exclusion Criteria: * Thyroid dysfunction. * Hyperprolactinemia. * Diabetes mellitus. * Congenital adrenal hyperplasia. * Adrenal causes of hyperandrogenism. * Use of insulin-sensitizing medications (e.g., metformin) during the study period. * Chronic liver disease. * Chronic kidney disease. * Contraindications to pregnancy. * Contraindications or hypersensitivity to inositol or 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.

Polycystic ovary syndrome Polycystic ovary syndrome (PCOS) women

Contacts and locations

Locations

  • Kafrelsheikh University Hospital

    Kafr ash Shaykh, Kafr el-Sheikh Governorate, 33511, Egypt

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