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Myo-Inositol for Infertility in PCOS

This study is looking at whether myo-inositol and D-chiro inositol supplements can help women with Polycystic Ovary Syndrome (PCOS) become pregnant. Participants will receive either the inositol supplement or a placebo (an inactive substance that looks the same) along with letrozole, a medication used to help with ovulation. The study aims to see if the inositol supplement increases the chances of clinical pregnancy. You may be able to join if you are a woman aged 18-36, want to get pregnant, have PCOS with irregular ovulation, and meet other specific health criteria. The study's status is currently unclear, and it plans to enroll 168 participants.

Study design
This is a double-blind randomized clinical trial, meaning neither you nor the research team will know if you are receiving the inositol supplement or the placebo. About 168 women will be split into two groups.
What's involved
You will have a screening visit including blood pressure, heart rate, weight, height, and blood tests. You will also have a transvaginal ultrasound. You will take either the inositol or placebo powder twice daily and letrozole for up to 5 treatment cycles or until pregnancy.
Compensation
Not stated in the trial record.
Follow-up
The primary goal of the study, clinical pregnancy, will be measured through study completion, which is an average of 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04407754

Myo-Inositol for Infertility in PCOS

Active, Not Recruiting
NAAges 18–36InterventionalSupportive care
University of Oklahoma
~168 participants
Updated 2026-05-12 on ClinicalTrials.gov
What's tested:Inositol supplementPlacebo supplement

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Clinical pregnancy
Measured over Through study completion, an average of 6 months

Conditions

Polycystic Ovary Syndrome

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NCT04407754

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • OUHSC Reproductive Medicine Clinic

    Oklahoma City, Oklahomano site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Heather Burks, MD · PRINCIPAL_INVESTIGATOR · OUHSC

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Clinical pregnancyThrough study completion, an average of 6 months

    Clinical pregnancy will be defined as documentation of a viable intrauterine pregnancy as noted by visualization of fetal heart motion on ultrasonography.