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NCT Number: NCT02119117

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

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.

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Key information

Age range

36 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

REACh

Charlotte, North Carolina, 28207, United States

About this study

Brief Summary

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • BMI >39
  • Active smoker
  • Blood serum baseline level of CoQ10 ≥2.20 µg/mL
  • Prior use of CoQ10
  • Type II diabetes mellitus

Treatment and study plan

CoQ10

Dietary Supplement

This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF

Placebo

Dietary Supplement

This is a placebo which will be administered daily to the patient for 3 months prior to IVF.

Primary outcomes

  1. Embryo mitochondrial DNA (mtDNA)

    Time frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts

Secondary outcomes

  1. preimplantation chromosomal aneuploidy

    Time frame: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts

Sponsors and collaborators

Lead sponsor

Reproductive Endocrinology Associates of Charlotte

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2014
Registry last updated
May 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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