Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial
University of Oklahoma
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.
Description
At the screening visit, blood pressure and heart rate will be measured, weight and height obtained and body mass index calculated (kg/m2). If not already completed at their new patient visit, transvaginal ultrasound will be performed to assess uterine anatomy and obtain antral follicle count, TSH, prolactin, and testosterone will be drawn, and serum samples will be obtained and analyzed for metabolic parameters (fasting lipids, insulin, and complete metabolic panel). One additional tube of blood will be drawn to store for potential future analysis. Once enrolled, randomization will occur and s…
Eligibility
- Age range
- 18–36 years
- Sex
- All
- Healthy volunteers
- No
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 anot…
Interventions
- Dietary SupplementInositol supplement
Inositol supplements given to inositol arm
- Dietary SupplementPlacebo supplement
Placebo supplement given to placebo arm
Location
- OUHSC Reproductive Medicine ClinicOklahoma City, Oklahoma