Trial record 2 of 28 for:    coenzyme Q10 AND mitochondrial

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2016 by Reproductive Endocrinology Associates of Charlotte
Sponsor:
Information provided by (Responsible Party):
Reproductive Endocrinology Associates of Charlotte
ClinicalTrials.gov Identifier:
NCT02119117
First received: April 14, 2014
Last updated: January 8, 2016
Last verified: January 2016
  Purpose

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.


Condition Intervention
Mitochondrial DNA
Aneuploidy
Dietary Supplement: CoQ10
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Blastocyst Aneuploidy Rates From Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Reproductive Endocrinology Associates of Charlotte:

Primary Outcome Measures:
  • Embryo mitochondrial DNA (mtDNA) [ Time Frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • preimplantation chromosomal aneuploidy [ Time Frame: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: sugar pill
Group 2 will receive a placebo of CoQ10
Dietary Supplement: Placebo
This is a placebo which will be administered daily to the patient for 3 months prior to IVF.
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
This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF

Detailed Description:
Brief Summary
  Eligibility

Ages Eligible for Study:   36 Years to 42 Years   (Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02119117

Contacts
Contact: Jack L Crain, MD 704-343-3400 ext 3101 jack.crain@integramed.com

Locations
United States, North Carolina
REACh Recruiting
Charlotte, North Carolina, United States, 28207
Contact: Jack L Crain, MD    704-343-3400 ext 3101    jack.crain@integramed.com   
Principal Investigator: Jack L Crain, MD         
Sponsors and Collaborators
Reproductive Endocrinology Associates of Charlotte
Investigators
Principal Investigator: Jack L Crain, MD Reproductive Endocrinology Associates of Charlotte
  More Information

Responsible Party: Reproductive Endocrinology Associates of Charlotte
ClinicalTrials.gov Identifier: NCT02119117     History of Changes
Other Study ID Numbers: REACh-002 
Study First Received: April 14, 2014
Last Updated: January 8, 2016
Health Authority: United States: Institutional Review Board

Keywords provided by Reproductive Endocrinology Associates of Charlotte:
mtDNA
aneuploidy
IVF
blastocyst
COQ10

Additional relevant MeSH terms:
Aneuploidy
Chromosome Aberrations
Pathologic Processes
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Vitamins

ClinicalTrials.gov processed this record on August 28, 2016