Using myo-inositol to improve fertility in women with PCOS
Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial
This study is testing if adding myo-inositol to a fertility medication can help women with PCOS ovulate and get pregnant.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 168 (estimated) |
| Ages | 18 Years to 36 Years |
| Sex | All |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04407754 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of myo-inositol combined with letrozole for inducing ovulation in women diagnosed with polycystic ovary syndrome (PCOS). It is a double-blind, randomized study where participants will receive either a placebo or a blend of myo-inositol and D-chiro inositol alongside letrozole for up to five treatment cycles or until pregnancy is achieved. Participants will undergo various assessments, including metabolic parameter analysis and quality of life questionnaires, to evaluate the treatment's impact. The study aims to provide insights into the potential benefits of inositol supplementation in enhancing fertility outcomes for women with PCOS.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-36 with a desire for pregnancy and diagnosed with oligo- or anovulation due to PCOS.
Not a fit: Patients with infertility due to causes other than PCOS or those with uncontrolled thyroid dysfunction may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve ovulation rates and fertility outcomes for women with PCOS.
How similar studies have performed: Previous studies have shown promising results with inositol supplementation in improving metabolic and reproductive outcomes in women with PCOS, suggesting this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Oklahoma City, Oklahoma
- OUHSC Reproductive Medicine Clinic — Oklahoma City, Oklahoma, United States (Recruiting)
Study contacts
- Principal investigator: Heather Burks, MD — Ouhsc
- Study coordinator: Christy Zornes, MHR
- Email: christy-zornes@ouhsc.edu
- Phone: 4052718001
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.