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Dietary Supplement

Myo-Inositol + Letrozole for PCOS Infertility

N/A
Recruiting
Led By Heather Burks, MD
Research Sponsored by University of Oklahoma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Normal uterine cavity
Desire for pregnancy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through study completion, an average of 6 months
Awards & highlights

Study Summary

This trial will compare the effect of letrozole with a placebo, versus letrozole with inositols, on pregnancy rates in women undergoing ovulation induction. The trial will be double-blind, meaning that neither the participants nor the research team will know which treatment each person is receiving.

Who is the study for?
This trial is for women aged 18-36 who want to get pregnant but are dealing with infertility due to polycystic ovary syndrome (PCOS). They should have irregular or no ovulation, at least one open fallopian tube, a normal uterus, and a partner with sufficient sperm count. Women can't join if they've taken myo-inositol recently, used metformin within the last 6 weeks, have diabetes or other causes of infertility.Check my eligibility
What is being tested?
The study tests whether adding an inositol supplement to letrozole treatment improves fertility in PCOS patients compared to letrozole alone. Participants will receive either a placebo or an inositol blend without knowing which one until the end of up to five treatment cycles or until pregnancy occurs.See study design
What are the potential side effects?
Inositols are generally considered safe but may cause mild digestive issues like nausea or diarrhea. Letrozole can lead to hot flashes, fatigue, joint pain and increase the risk for multiple pregnancies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My uterine cavity is normal.
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I want to become pregnant.
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I am a woman aged between 18 and 36.
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My male partner has a sperm count of at least 14 million/mL.
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I have at least one open fallopian tube.
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I have PCOS with irregular periods and either high male hormones or many small cysts on my ovaries.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through study completion, an average of 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Clinical pregnancy

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Inositol ArmActive Control1 Intervention
This group will receive myo-inositol (2,000mg) plus d-chiro-inositol (50mg) supplement powder twice daily.
Group II: Control ArmPlacebo Group1 Intervention
This group will receive placebo powder twice daily.

Find a Location

Who is running the clinical trial?

University of OklahomaLead Sponsor
455 Previous Clinical Trials
97,953 Total Patients Enrolled
Heather Burks, MDPrincipal InvestigatorOUHSC

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any eligibility criteria for participants in this clinical research?

"In order to be eligible, potential participants must meet two criteria: they must have sclerocystic ovaries and lie within the age range of 18-36 years old. At this time, 168 individuals are being recruited for the trial."

Answered by AI

Is this research endeavor still accepting participants?

"Indeed, clinicaltrials.gov displays that this medical trial is currently enrolling participants; it was initially published on December 19th 2020 and modified most recently on May 17th 2022. The experiment requires 168 volunteers from a single site."

Answered by AI

What is the total number of individuals taking part in this research?

"Affirmative. Data hosted on clinicaltrials.gov indicates that this medical study is actively recruiting; it was first published December 19th 2020 and most recently updated May 17th 2022. The trial currently requires 168 patients to be recruited at one location."

Answered by AI

Is it feasible for individuals under the age of 35 to partake in this research study?

"As per the trial's entry requirements, only individuals between 18 to 36 years of age can be included in this clinical study."

Answered by AI

Who else is applying?

What site did they apply to?
OUHSC Reproductive Medicine Clinic
What portion of applicants met pre-screening criteria?
Met criteria

Why did patients apply to this trial?

Have been diagnosed with pcos for over 15 years, never been pregnant and want to achieve a successful pregnancy.
PatientReceived 2+ prior treatments
~16 spots leftby Aug 2024