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

This study has been completed.
Sponsor:
Collaborator:
Lo.Li. Pharma, Ltd.
Information provided by (Responsible Party):
Scott Roseff, MD, Palm Beach Center for Reproductive Medicine
ClinicalTrials.gov Identifier:
NCT01290432
First received: February 3, 2011
Last updated: May 24, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention
Infertility, Female
Dietary Supplement: Inofolic Plus

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women

Resource links provided by NLM:


Further study details as provided by Palm Beach Center for Reproductive Medicine:

Primary Outcome Measures:
  • Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels) [ Time Frame: Three Months ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: February 2011
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Inofolic Plus
Patients are given Inofolic Plus to see if the AMH changes over a period of up to 90 days.
Dietary Supplement: Inofolic Plus
Inofolic Plus contains folic acid and myoinositol and melatonin
Other Name: folic acid, myoinositol, and melatonin in combination

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.

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01290432

Locations
United States, Florida
Palm Beach Center for Reproductive Medicine
Wellington, Florida, United States, 33414
Sponsors and Collaborators
Palm Beach Center for Reproductive Medicine
Lo.Li. Pharma, Ltd.
Investigators
Principal Investigator: Scott Roseff, MD Palm Beach Center for Reproductive Medicine
  More Information

Publications:
Responsible Party: Scott Roseff, MD, Principal Investigator, Palm Beach Center for Reproductive Medicine
ClinicalTrials.gov Identifier: NCT01290432     History of Changes
Other Study ID Numbers: Roseff-01
Study First Received: February 3, 2011
Last Updated: May 24, 2012
Health Authority: Italy: National Institute of Health

Keywords provided by Palm Beach Center for Reproductive Medicine:
female fertility
ovarian reserve
oocyte quality
oocyte quantity
antimullerian hormone
AMH
dietary supplements
inofolic plus
myoinositol
folic acid

Additional relevant MeSH terms:
Infertility
Infertility, Female
Genital Diseases, Male
Genital Diseases, Female
Folic Acid
Vitamin B Complex
Inositol
Melatonin
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Central Nervous System Depressants
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014