Myo-Inositol for Infertility in PCOS

Launched by UNIVERSITY OF OKLAHOMA · May 27, 2020

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a supplement called myo-inositol on women with Polycystic Ovary Syndrome (PCOS) who are having difficulty getting pregnant. The trial will compare two groups: one group will receive a combination of letrozole (a medication that helps with ovulation) and myo-inositol, while the other group will receive letrozole and a placebo (a harmless pill that looks the same but has no active ingredients). The goal is to see if adding myo-inositol helps women ovulate and achieve pregnancy more effectively.

To be eligible for this study, participants need to be women aged 18 to 36 who want to become pregnant and have been diagnosed with PCOS-related ovulation problems. They must also have at least one functioning fallopian tube and a normal uterine cavity. During the trial, everyone involved, including the participants and researchers, will not know which treatment each participant is receiving to ensure fairness in the results. It’s important to know that women with other fertility issues or certain health conditions may not qualify for this trial. If you think you might be a good fit and are interested in participating, this study could provide valuable insights into improving fertility for women with PCOS.

Gender

ALL

Eligibility criteria

• 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.