CClinicalTrials.gg
CompletedNCT01290432Updated May 25, 2012

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

An interventional study of Inofolic Plus in Infertility, Female, sponsored by Palm Beach Center for Reproductive Medicine. Completed at 1 site in United States. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-05-25.

Sponsored by Palm Beach Center for Reproductive Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
15
Allocation
Not applicable
Ages
18 Years to 42 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Infertility, Female

Keywords

  • female fertility
  • ovarian reserve
  • oocyte quality
  • oocyte quantity
  • antimullerian hormone
  • AMH
  • dietary supplements
  • inofolic plus
  • myoinositol
  • folic acid
03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 15 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

This is the only study on the registry with Palm Beach Center for Reproductive Medicine as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Ongoing history of illicit drug or tobacco use
  • Ovarian surgery within 90 days of signing the consent form
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
15 participants (actual)

Study arms

  • 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

Interventions

  • Dietary supplementInofolic Plus

    Inofolic Plus contains folic acid and myoinositol and melatonin

    Also known as: folic acid, myoinositol, and melatonin in combination

06

What researchers measure

Primary outcomes

  1. Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels)

    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.

    Time frame: Three Months

07

Study locations

1 site
  • Palm Beach Center for Reproductive Medicine
    Wellington, Florida 33414, United States
08

References and documents

Publications

  • Tamura H, Takasaki A, Miwa I, Taniguchi K, Maekawa R, Asada H, Taketani T, Matsuoka A, Yamagata Y, Shimamura K, Morioka H, Ishikawa H, Reiter RJ, Sugino N. Oxidative stress impairs oocyte quality and melatonin protects oocytes from free radical damage and improves fertilization rate. J Pineal Res. 2008 Apr;44(3):280-7. doi: 10.1111/j.1600-079X.2007.00524.x. PubMed 18339123 ↗
  • Tamura H, Nakamura Y, Korkmaz A, Manchester LC, Tan DX, Sugino N, Reiter RJ. Melatonin and the ovary: physiological and pathophysiological implications. Fertil Steril. 2009 Jul;92(1):328-43. doi: 10.1016/j.fertnstert.2008.05.016. Epub 2008 Sep 18. PubMed 18804205 ↗
  • Papaleo E, Unfer V, Baillargeon JP, Fusi F, Occhi F, De Santis L. Myo-inositol may improve oocyte quality in intracytoplasmic sperm injection cycles. A prospective, controlled, randomized trial. Fertil Steril. 2009 May;91(5):1750-4. doi: 10.1016/j.fertnstert.2008.01.088. Epub 2008 May 7. PubMed 18462730 ↗
  • Papaleo E, Unfer V, Baillargeon JP, Chiu TT. Contribution of myo-inositol to reproduction. Eur J Obstet Gynecol Reprod Biol. 2009 Dec;147(2):120-3. doi: 10.1016/j.ejogrb.2009.09.008. Epub 2009 Oct 2. PubMed 19800728 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 25, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01290432
Lead sponsor
Palm Beach Center for Reproductive Medicine
Collaborators
Lo.Li. Pharma, Ltd.
Responsible party
Scott Roseff, MD (Principal Investigator, Palm Beach Center for Reproductive Medicine) — Principal investigator
First posted
Feb 7, 2011
Start date
Feb 2011
Primary completion
Feb 2012
Completion
Feb 2012
Last update
May 25, 2012

Study contacts

Scott Roseff, MD
principal investigator · Palm Beach Center for Reproductive Medicine

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.

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