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

NCT02119117 | Completed

• 1 other identifier: REACh-002
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mitochondrial DNA; Aneuploidy

Keywords

mtDNA; aneuploidy; IVF; blastocyst; COQ10

Outcome Measures

Primary Outcomes (1)

• Embryo mitochondrial DNA (mtDNA)

  mtDNA levels will be assesed from day 5 or day 6 blastocysts

Secondary Outcomes (1)

• preimplantation chromosomal aneuploidy

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

Study Arms (2)

sugar pill

PLACEBO COMPARATOR

Group 2 will receive a placebo of CoQ10

Dietary Supplement: Placebo

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).

Dietary Supplement: CoQ10

Interventions

CoQ10 DIETARY_SUPPLEMENT

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

CoQ10

Placebo DIETARY_SUPPLEMENT

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

sugar pill

Eligibility Criteria

• Age: 36 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Reproductive Endocrinology Associates of Charlotte: lead

Study Sites (1)

REACh

Charlotte, North Carolina, 28207, United States

Location

MeSH Terms

Conditions

Aneuploidy

Interventions

coenzyme Q10

Condition Hierarchy (Ancestors)

Chromosome Aberrations; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jack L Crain, MD

  Reproductive Endocrinology Associates of Charlotte

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: May 4, 2018

Record last verified: 2018-05

Locations

US (1)