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Can adding inositol boost Letrozole's ovulation power in PCOS?

NCT ID NCT07873294

Symptom relief Sponsor: Al-Azhar University 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Oct 14, 2026 · Last updated Oct 15, 2026 · Updated 1 time

Summary

Polycystic ovary syndrome (PCOS) often disrupts ovulation, making it harder for women to conceive. This trial compares two approaches for inducing ovulation: letrozole alone versus letrozole combined with inositol. Researchers will enroll 100 women with PCOS and measure follicle-stimulating hormone levels to see which treatment triggers ovulation more effectively.

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 ovulation-inducing drug, tested alone and combined with inositol
What this could lead to
If the combination works better, it could give women with PCOS a more effective option for inducing ovulation.
What could go wrong
This is a small, single-center study, so results may not hold up in larger or more diverse groups. Inositol is a supplement, and its added benefit over letrozole alone is not established.

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

100 people

The number who actually took part.

Started

Aug 2025

Finished

Aug 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: * Diagnosis of PCOS according to the Rotterdam criteria, requiring the presence of at least two of the following three features: oligo-ovulation or anovulation; clinical and/or biochemical hyperandrogenism; Polycystic ovarian morphology on ultrasonography. * According to the prespecified study protocol, polycystic ovarian morphology was defined as the presence of ≥12 follicles measuring 2-9 mm in diameter and/or ovarian volume \>10 mL in at least one ovary. * BMI \<30 kg/m². * Documented anovulation, supported by a luteal serum progesterone concentration \<3 ng/mL. * Bilateral tubal patency confirmed by hysterosalpingography. * Absence of another identifiable female infertility factor. * Normal semen analysis of the male partner. Exclusion Criteria: * Persistent hyperprolactinemia. * Congenital adrenal hyperplasia or other adrenal disorders associated with androgen excess. * Pituitary insufficiency. * Clinically significant thyroid dysfunction affecting ovulation. * Previous ovarian surgery. * Use of ovulation-induction agents, insulin-sensitizing medications or other oral hypoglycemic agents, hormonal contraceptives, or anti-androgen medications within 60 days before enrollment. * Known hypersensitivity or contraindication to letrozole or inositol.

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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

Contacts and locations

Locations

  • Al-Azhar University Hospital Assuit branch

    Asyut, Egypt

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