Using myo-inositol to improve fertility in women with PCOS
Official title: Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial
Run by University of Oklahoma · NCT04407754 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if adding myo-inositol to a fertility medication can help women with PCOS ovulate and get pregnant.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 36 Years |
| Sex | All |
| Enrollment | 168 (estimated) |
| Sponsor | University of Oklahoma Academic / other |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT04407754 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18-36 with a desire for pregnancy and diagnosed with oligo- or anovulation due to PCOS.
✕Probably not a fit
Patients with infertility due to causes other than PCOS or those with uncontrolled thyroid dysfunction may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
Why it matters
Potential benefit: If successful, this study could improve ovulation rates and fertility outcomes for women with PCOS.
How similar studies have gone: 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.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Precision acupuncture and lifestyle for PCOS
This trial tests whether a precision acupuncture approach combined with a personalized lifestyle plan helps improve insulin resistance in people with PCOS compared with conventional acupuncture and standard lifestyle changes.
-
Orlistat for metabolic and hormonal features in women with PCOS
This trial tests whether adding orlistat to lifestyle advice helps improve metabolic and hormonal aspects in women with PCOS compared to lifestyle advice alone.
-
Physical activity program for women with PCOS and fatty pancreas plus subclinical hypothyroidism
A program of exercise is being tested to see if it helps women with PCOS who also have fatty pancreas and subclinical hypothyroidism, compared to usual care.
-
Glucose monitoring in women with polycystic ovary syndrome
This project will use continuous glucose monitors to see if daily glucose patterns differ among adult women with different PCOS phenotypes.
-
Adding regular exercise to a low‑calorie diet and metformin for women with PCOS and asthma
This study will test whether adding regular treadmill walking to a low‑calorie diet and daily metformin helps women who have both PCOS and asthma.
-
Identifying insulin-resistant PCOS with LMNA-related lipodystrophy in young women
We’re testing whether women with a genetic insulin resistance and lipodystrophy differ from women with PCOS by age and BMI matching.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.