RECRUITING

Myo-Inositol for Infertility in PCOS

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Myo-Inositol as an Adjuvant to Letrozole for Infertility in PolyCystic Ovary Syndrome (MALI-PCOS): a Randomized Pilot Trial

Quick Facts

Study Start:2020-12-19
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04407754

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 36 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Female patient age 18-36
  2. * Desire for pregnancy
  3. * 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
  4. * At least one patent fallopian tube
  5. * Normal uterine cavity
  6. * Male partner with sperm concentration of at least 14 million/mL in at least one ejaculate.
  1. * Cause of anovulation other than PCOS such as uncontrolled thyroid dysfunction or hyperprolactinemia
  2. * Presence of another major infertility factor
  3. * Diabetes
  4. * Contraindication to pregnancy
  5. * Myo-inositol use \< 3 months prior to study enrollment
  6. * Concomitant metformin use. Previous use is allowed with last use at least 6 weeks prior to randomization.

Contacts and Locations

Study Contact

Christy Zornes, MHR
CONTACT
4052718001
christy-zornes@ouhsc.edu
Kyra Woods, BA
CONTACT
4052718001
kyra-woods@ouhsc.edu

Principal Investigator

Heather Burks, MD
PRINCIPAL_INVESTIGATOR
OUHSC

Study Locations (Sites)

OUHSC Reproductive Medicine Clinic
Oklahoma City, Oklahoma, 73104
United States

Collaborators and Investigators

Sponsor: University of Oklahoma

  • Heather Burks, MD, PRINCIPAL_INVESTIGATOR, OUHSC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-12-19
Study Completion Date2025-12

Study Record Updates

Study Start Date2020-12-19
Study Completion Date2025-12

Terms related to this study

Additional Relevant MeSH Terms

  • Polycystic Ovary Syndrome