Status:
RECRUITING
Myo-Inositol for Infertility in PCOS
Lead Sponsor:
University of Oklahoma
Conditions:
Polycystic Ovary Syndrome
Eligibility:
All Genders
18-36 years
Phase:
NA
Brief Summary
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 ach...
Detailed Description
At the screening visit, blood pressure and heart rate will be measured, weight and height obtained and body mass index calculated (kg/m2). If not already completed at their new patient visit, transvag...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT04407754
Start Date
February 7 2022
End Date
February 1 2026
Last Update
December 18 2025
Active Locations (1)
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1
OUHSC Reproductive Medicine Clinic
Oklahoma City, Oklahoma, United States, 73104