Ignite Creation Date:
2024-05-05 @ 11:16 PM
Last Modification Date:
2024-10-26 @ 10:31 AM
Study NCT ID:
NCT01290432
Status:
COMPLETED
Last Update Posted:
2012-05-25
First Post:
2011-02-03
Brief Title:
The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women
Sponsor:
Palm Beach Center for Reproductive Medicine
Organization:
Palm Beach Center for Reproductive Medicine
Study Overview
Official Title:
The Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve Parameters in Subfertile Women
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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 sleepwake 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
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 sleepwake 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None