The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women
Condition: Infertility, Female
MeSH terms: Infertility; Infertility, Female
Study type: Interventional

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.
    

Intervention name(s): Inofolic Plus
Intervention type(s): Dietary Supplement
Intervention description(s): Inofolic Plus contains folic acid and myoinositol and melatonin
Other intervention name(s): folic acid, myoinositol, and melatonin in combination
Intervention MeSH terms: Folic Acid; Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: female fertility; ovarian reserve; oocyte quality; oocyte quantity; antimullerian hormone; AMH; dietary supplements; inofolic plus; myoinositol; folic acid