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CompletedNCT02119117Updated May 4, 2018

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

An interventional study of CoQ10 and Placebo in Mitochondrial DNA and Aneuploidy, sponsored by Reproductive Endocrinology Associates of Charlotte. Completed at 1 site in United States. Open to female participants aged 36 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-04.

Sponsored by Reproductive Endocrinology Associates of Charlotte · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
36 Years to 42 Years
Sex
Female
01

Study 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.

Read the detailed description

Brief Summary

02

Conditions studied

  • Mitochondrial DNA
  • Aneuploidy

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Keywords

  • mtDNA
  • aneuploidy
  • IVF
  • blastocyst
  • COQ10
03

In context

Aneuploidy

87 studies on the registry are indexed under Aneuploidy; 12 are open to participants now.

This study's enrollment of 21 is below the median of 152 across 36 interventional studies indexed under Aneuploidy.

Browse Aneuploidy studies →

Lead sponsor

This is the only study on the registry with Reproductive Endocrinology Associates of Charlotte as lead sponsor.

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

04

Who can participate

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

Inclusion criteria

  1. 36-42 years old
  2. Must present with an AMH level ≤2.0 ng/mL
  3. 1st cycle of IVF treatment
  4. Antral follicle count >5 and \<20

Exclusion criteria

Exclusion Criteria:

  1. BMI >39
  2. Active smoker
  3. Blood serum baseline level of CoQ10 ≥2.20 µg/mL
  4. Prior use of CoQ10
  5. Type II diabetes mellitus
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
21 participants (actual)

Study arms

  • Placebo comparator
    sugar pill

    Group 2 will receive a placebo of CoQ10

    Dietary Supplement: Placebo

  • Experimental
    CoQ10

    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).

    Dietary Supplement: CoQ10

Interventions

  • Dietary supplementCoQ10

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

  • Dietary supplementPlacebo

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

06

What researchers measure

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

07

Study locations

1 site
  • REACh
    Charlotte, North Carolina 28207, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02119117
Lead sponsor
Reproductive Endocrinology Associates of Charlotte
Responsible party
Sponsor
First posted
Apr 21, 2014
Start date
Apr 2014
Primary completion
May 2018
Completion
May 2018
Last update
May 4, 2018

Study contacts

Jack L Crain, MD
principal investigator · Reproductive Endocrinology Associates of Charlotte

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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