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Can a Sugar-Like supplement boost fertility in PCOS?

NCT ID NCT04407754

Disease control Sponsor: University of Oklahoma 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding a myo-inositol supplement to the standard fertility drug letrozole helps women with polycystic ovary syndrome (PCOS) achieve pregnancy. About 168 women will receive either the supplement or a placebo alongside letrozole for up to 5 treatment cycles. The goal is to see if the combination leads to more clinical pregnancies.

What this could mean

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

Active substance
myo-inositol and D-chiro inositol supplement
What this could lead to
If it works, this could offer a simple, low-cost supplement to boost pregnancy chances for women with PCOS taking letrozole.
What could go wrong
This is a small pilot trial, so results may not be definitive. The supplement might not improve pregnancy rates over letrozole alone.

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

168 people

The number who actually took part.

Started

Feb 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

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 36 years

Sex

Anyone

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: * Female patient age 18-36 * Desire for pregnancy * Diagnosis of oligo- or anovulation secondary to polycystic ovary syndrome -All subjects must have ovulatory dysfunction and at least one of the remaining two criteria:hyperandrogenism or polycystic ovarian morphology on ultrasound * At least one patent fallopian tube * Normal uterine cavity * Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate. Exclusion Criteria: * Cause of anovulation other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia * Presence of another major infertility factor * Diabetes * Contraindication to pregnancy * Myo-inositol use \< 3 months prior to study enrollment * Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.

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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

  • OUHSC Reproductive Medicine Clinic

    Oklahoma City, Oklahoma, 73104, United States

More trials for these conditions

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