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临床试验/NCT02119117
NCT02119117已完成不适用

Blastocyst Aneuploidy Rates From Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study

Reproductive Endocrinology Associates of Charlotte2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2014年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
21
试验地点
2
主要终点
Embryo mitochondrial DNA (mtDNA)

研究概览

简要总结

Pregnancy rates for women over 35 years old are significantly lower when compared to younger women. One of the causes for this decrease is believed to be chromosomal aneuploidy. Chromosomal aneuploidy is a natural phenomena and occurs in women of every age and has been implicated in spontaneous miscarriages, and preimplantation embryo wastage (Hassold and Hunt, 2001).

As maternal age increases, so too does the incidence of chromosomal aneuploidy. Embryo quality from older patients undergoing IVF tends to be reduced and associated with higher rates of chromosomal abnormalities when compared to good quality embryos (Munne et al., 1995).

Chromosomal aneuploidy derives from the improper segregation of chromosomes during preimplantation development. The process of segregation, or mitosis, includes synthesis of the complete genome, equal division of chromosomes to opposite poles by the spindle apparatus, and separation of the two cells by cytokinesis, yielding two chromosomally identical cells. The entire process of cellular and genetic replication requires energy in the form of adenosine tri phosphate (ATP). ATP is mainly produced in mitochondria in the process known as the electron transport chain (ETC). There are many important molecules required for ATP production, CoQ10 can act as the appropriate carrier of electrons through the ETC. When a deficiency in CoQ10 is present, ATP production is decreased resulting in aneuploidy (Bentov et al., 2013). Similarly, research has shown that chromosome alignment and spindle formation are affected by mtDNA copy number (Ge et al., 2012). It has also been shown that the transfer of ooplasm from young, healthy oocyte donors into oocytes of women with repeated embryonic failure has result in children with subsequent mitochondrial heteroplasmy (Cohen et al., 1998).

CoQ10 concentrations have been shown to decrease as age increases (Bentov et al., 2011). Consequently, the decrease in CoQ10 concentrations seen in older women may cause an increase in chromosomal aneuploidy in subsequent embryos (Bentov et al., 2013). In this pilot study, we test the hypothesis that the supplementation of CoQ10 prior to an IVF cycle can increase mitochondrial DNA activity and possibly decrease chromosomal aneuploidy in AMA patients.

详细描述

Brief Summary

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 36-42 years old
  • Must present with an AMH level ≤2.0 ng/mL
  • 1st cycle of IVF treatment
  • Antral follicle count >5 and <20

排除标准

  • Active smoker
  • Blood serum baseline level of CoQ10 ≥2.20 µg/mL
  • Prior use of CoQ10
  • Type II diabetes mellitus

研究组 & 干预措施

sugar pill

Placebo Comparator

Group 2 will receive a placebo of CoQ10

干预措施: Placebo (Dietary Supplement)

CoQ10

Experimental

Patients will be divided into 2 groups. Group 1 will be treated with an oral supplement, 125 mg/twice daily of CoQ10 (NeoQ10, Theralogix, Rockville, Maryland, USA) for 3 months prior to IVF. This dosage will equate to a Cmax of 6.89 ug/ml (Liu and Artmann, 2009).

干预措施: CoQ10 (Dietary Supplement)

结局指标

主要结局

Embryo mitochondrial DNA (mtDNA)

时间窗: mtDNA levels will be assesed from day 5 or day 6 blastocysts

次要结局

  • preimplantation chromosomal aneuploidy(aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts)

研究者

发起方
Reproductive Endocrinology Associates of Charlotte
申办方类型
Other
责任方
Sponsor

研究点 (2)

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