Myo-Inositol for Infertility in PCOS

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

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.

Conditions2

Locations1 site

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