Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DIETARY_SUPPLEMENT

Inositol supplement

Inositol supplements given to inositol arm

DIETARY_SUPPLEMENT

Placebo supplement

Placebo supplement given to placebo arm

Locations (1)

OUHSC Reproductive Medicine Clinic
Oklahoma City, Oklahoma, United States