Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
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|ClinicalTrials.gov Identifier: NCT02119117|
Recruitment Status : Unknown
Verified January 2016 by Reproductive Endocrinology Associates of Charlotte.
Recruitment status was: Recruiting
First Posted : April 21, 2014
Last Update Posted : January 12, 2016
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 or disease||Intervention/treatment||Phase|
|Mitochondrial DNA Aneuploidy||Dietary Supplement: CoQ10 Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, 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|
|Study Start Date :||April 2014|
|Estimated Primary Completion Date :||May 2016|
|Estimated Study Completion Date :||August 2016|
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.
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
- Embryo mitochondrial DNA (mtDNA) [ Time Frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts ]
- preimplantation chromosomal aneuploidy [ Time Frame: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02119117
|Contact: Jack L Crain, MD||704-343-3400 ext email@example.com|
|United States, North Carolina|
|Charlotte, North Carolina, United States, 28207|
|Contact: Jack L Crain, MD 704-343-3400 ext 3101 firstname.lastname@example.org|
|Principal Investigator: Jack L Crain, MD|
|Principal Investigator:||Jack L Crain, MD||Reproductive Endocrinology Associates of Charlotte|