RecruitingNot ApplicableNCT04407754

Myo-Inositol for Infertility in PCOS

Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial

Sponsor

University of Oklahoma

Enrollment

168 participants

Start Date

Feb 7, 2022

Study Type

INTERVENTIONAL

Conditions

Polycystic Ovary Syndrome

Summary

This will be a prospective, double-blind randomized clinical trial of letrozole and placebo versus letrozole and inositols for up to 5 treatment cycles of ovulation induction or until pregnancy is achieved. All participants and members of the research team will be blinded to the treatment arms. Placebo and inositol supplement will be packaged to appear the same, tested, and packaged by a commercial supply company. The inositols will be a 40:1 blend of myo-inositol and D-chiro inositol.

Eligibility

Min Age: 18 YearsMax Age: 36 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether myo-inositol (a naturally occurring sugar compound) can help women with polycystic ovary syndrome (PCOS) ovulate regularly and improve their chances of getting pregnant. **You may be eligible if...** - You are a woman between 18 and 36 years old - You want to become pregnant - You have been diagnosed with PCOS, including irregular or absent ovulation - You have at least one open fallopian tube - Your uterus is normal - Your male partner has an adequate sperm count **You may NOT be eligible if...** - Your irregular ovulation is caused by something other than PCOS (like thyroid problems) - You have diabetes - You are currently taking metformin (must stop at least 6 weeks before the study) - You used myo-inositol within the last 3 months - You have another major cause of infertility Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTInositol supplement

Inositol supplements given to inositol arm

DIETARY_SUPPLEMENTPlacebo supplement

Placebo supplement given to placebo arm

Locations(1)

OUHSC Reproductive Medicine Clinic

Oklahoma City, Oklahoma, United States

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NCT04407754

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