Myo-Inositol for Infertility in PCOS

NCT04407754 | Recruiting

• 1 other identifier: 12103
• Study Type: interventional
• Target: 168
• Locations: 1 country
• Sites: 1

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 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

Polycystic Ovary Syndrome

Outcome Measures

Primary Outcomes (1)

• Clinical pregnancy

  Clinical pregnancy will be defined as documentation of a viable intrauterine pregnancy as noted by visualization of fetal heart motion on ultrasonography.

  Through study completion, an average of 6 months

Study Arms (2)

Control Arm

PLACEBO COMPARATOR

This group will receive placebo powder twice daily.

Dietary Supplement: Placebo supplement

Inositol Arm

ACTIVE COMPARATOR

This group will receive myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement powder twice daily.

Dietary Supplement: Inositol supplement

Interventions

Placebo supplement DIETARY_SUPPLEMENT

Placebo supplement given to placebo arm

Control Arm

Inositol supplement DIETARY_SUPPLEMENT

Inositol supplements given to inositol arm

Inositol Arm

Eligibility Criteria

• Age: 18 Years - 36 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

OUHSC Reproductive Medicine Clinic

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

MeSH Terms

Conditions

Polycystic Ovary Syndrome

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Heather Burks, MD

  OUHSC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christy Zornes, MHR

CONTACT

4052718001; christy-zornes@ouhsc.edu

Kyra Woods, BA

CONTACT

4052718001; kyra-woods@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2020
• First Posted: May 29, 2020
• Study Start: February 7, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)