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临床试验/NCT01290432
NCT01290432已完成不适用

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

Palm Beach Center for Reproductive Medicine2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2011年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
15
试验地点
2
主要终点
Potential Effects of Inofolic Plus on Abnormal Ovarian Reserve (AMH Levels)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Palm Beach Center for Reproductive Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Scott Roseff, MD

Principal Investigator

Palm Beach Center for Reproductive Medicine

研究点 (2)

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