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Dietary Supplement

Myo-Inositol + Letrozole for PCOS Infertility

N/A
Recruiting
Led By Heather Burks, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal uterine cavity
Female patient age 18-36
Must not have
Cause of anovulation other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia
Diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months

Summary

This trial will compare the effect of letrozole with a placebo, versus letrozole with inositols, on pregnancy rates in women undergoing ovulation induction. The trial will be double-blind, meaning that neither the participants nor the research team will know which treatment each person is receiving.

Who is the study for?
This trial is for women aged 18-36 who want to get pregnant but are dealing with infertility due to polycystic ovary syndrome (PCOS). They should have irregular or no ovulation, at least one open fallopian tube, a normal uterus, and a partner with sufficient sperm count. Women can't join if they've taken myo-inositol recently, used metformin within the last 6 weeks, have diabetes or other causes of infertility.
What is being tested?
The study tests whether adding an inositol supplement to letrozole treatment improves fertility in PCOS patients compared to letrozole alone. Participants will receive either a placebo or an inositol blend without knowing which one until the end of up to five treatment cycles or until pregnancy occurs.
What are the potential side effects?
Inositols are generally considered safe but may cause mild digestive issues like nausea or diarrhea. Letrozole can lead to hot flashes, fatigue, joint pain and increase the risk for multiple pregnancies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My uterine cavity is normal.
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I am a woman aged between 18 and 36.
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My male partner has a sperm count of at least 14 million/mL.
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I have at least one open fallopian tube.
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I have PCOS with irregular periods and either high male hormones or many small cysts on my ovaries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My ovulation issues are not due to PCOS but another untreated condition.
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I have diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Clinical pregnancy

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Inositol ArmActive Control1 Intervention
This group will receive myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement powder twice daily.
Group II: Control ArmPlacebo Group1 Intervention
This group will receive placebo powder twice daily.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
473 Previous Clinical Trials
93,513 Total Patients Enrolled
Heather Burks, MDPrincipal InvestigatorOUHSC
~19 spots leftby Jun 2025
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