Myo-Inositol for Infertility in PCOS

Description

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.

Conditions

Polycystic Ovary Syndrome

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Study Overview

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Study Details

Study overview

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.

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

Myo-Inositol for Infertility in PCOS

Condition
Polycystic Ovary Syndrome
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

OUHSC Reproductive Medicine Clinic, Oklahoma City, Oklahoma, United States, 73104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 36 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Heather Burks, MD, PRINCIPAL_INVESTIGATOR, OUHSC

Study Record Dates

2025-12