NCT04407754Active, not recruiting
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 · Last updated 12 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 168 (actual)
- First submitted
- 21 May 2020
- Start date
- 7 Feb 2022
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- University of Oklahoma
- NCT number
- NCT04407754
What you commit to
- Study type: Interventional
- Participants enrolled: 168
- From 7 Feb 2022 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Diabetes
Other
- Cause of anovulation other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia
- Presence of another major infertility factor
- Contraindication to pregnancy
Who the study is looking for
- 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.
Age in the registry: 18 years to 36 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| OUHSC Reproductive Medicine Clinic Coordinator of this site? Confirm its status | Oklahoma City | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.