The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women

Not Applicable

Completed

• Conditions: Infertility, Female
• Interventions: Dietary Supplement: Inofolic Plus

• Registration Number: NCT01290432
• Lead Sponsor: Palm Beach Center for Reproductive Medicine

Brief Summary

Dr. Roseff and his colleagues are conducting a study to evaluate the effectiveness of a novel substance (Inofolic Plus®) in improving oocyte (egg) parameters in subfertile female patients, as measured through Anti-Mullerian Hormone (AMH) blood levels.

Detailed Description

Inofolic Plus® contains several nutritional elements including myo-inositol, melatonin, and folic acid. Myo-inositol was found to be helpful in improving egg quality and/or quantity in women with an ovarian abnormality called polycystic ovarian syndrome as well as in women without the disorder undergoing assisted reproduction.

Myo-inositol and folic acid are compounds that belong to the family of B-vitamins. Inositol is normally found in several types of foods. Folic acid has been found to significantly decrease the incidence of certain types of birth defects in women taking sufficient amounts prior to and during pregnancy. Preliminary studies using myo-inositol and folic acid demonstrated improvement in egg quality in-vitro and in-vivo as well as multiple metabolic parameters in women with irregular menstrual cycles and certain types of hormone imbalances.

Melatonin is a potent antioxidant. Folic acid is not classified as an antioxidant but has been reported to have antioxidant-like activity. Antioxidants have been given to infertile men for years to improve egg parameters. Most recently, studies have documented the efficacy of antioxidant treatment on human egg parameters and fertilization rates, especially in the setting of in-vitro fertilization (IVF). Inofolic Plus® contains melatonin and folic acid. Dr. Roseff hypothesizes that Inofolic Plus® may be effective in correcting abnormal egg parameters in women. A woman may have abnormal eggs from being exposed to environmental and workplace toxins that generate oxygen free radicals in her body (known as reactive oxygen species, or ROS). These ROS circulate through the blood stream and can enter the ovaries where eggs are stored. Eggs may be sensitive to ROS, and damage from the ROS may result in poor egg quality or quantity or both. The combination of nutrients and antioxidants in Inofolic Plus® may help to correct these abnormalities. Melatonin is a natural hormone normally found in the brain. This hormone helps regulate sleep/wake cycles. Melatonin levels increase during the evening and remain high during the night. This elevated level of melatonin is thought to induce drowsiness. It is because of this effect that we recommend taking Inofolic Plus® in the late evening near bedtime.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-02-03
• Study First Submitted QC: 2011-02-03
• Study First Posted: 2011-02-07
• Primary Completion: 2012-02
• Study Completion: 2012-02
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-24
• Last Update Posted: 2012-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Female between 18 - 42 years of age
• Diagnosed with "Diminished Ovarian Reserve" (DOR)

Exclusion Criteria

• Ongoing history of illicit drug or tobacco use
• Ovarian surgery within 90 days of signing the consent form

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Inofolic Plus	Inofolic Plus	Patients are given Inofolic Plus to see if the AMH changes over a period of up to 90 days.

Primary Outcome Measures

Name	Time	Method
Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels)	Three Months	Women will receive Infolic Plus nightly for up to 90 days. Baseline AMH blood levels will be analyzed, and AMH titers will be checked monthly thereafter for the 90 day duration of the study.

Trial Locations

Locations (1)

Palm Beach Center for Reproductive Medicine; 🇺🇸 Wellington, Florida, United States