Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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Study Design

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Clinical Trial Details

NCT number	NCT02119117
Study type	Interventional
Source	Reproductive Endocrinology Associates of Charlotte
Contact
Status	Completed
Phase	N/A
Start date	April 2014
Completion date	May 2018

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

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

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms