Clinical trial · Interventional
Myo-Inositol for Infertility in PCOS
Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Inositol supplement | Dietary Supplement | — | UNRESOLVED |
| Placebo supplement | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- Control Arm
- description
- This group will receive placebo powder twice daily.
- interventionNames
- Dietary Supplement: Placebo supplement
- type
- ACTIVE_COMPARATOR
- label
- Inositol Arm
- description
- This group will receive myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement powder twice daily.
- interventionNames
- Dietary Supplement: Inositol supplement
Primary outcomes (1)
- measure
- Clinical pregnancy
- timeFrame
- Through study completion, an average of 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 36 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available