- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02119117
Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
Blastocyst Aneuploidy Rates From 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Charlotte, North Carolina, United States, 28207
- Reach
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: sugar pill
Group 2 will receive a placebo of CoQ10
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This is a placebo which will be administered daily to the patient for 3 months prior to IVF.
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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).
|
This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Embryo mitochondrial DNA (mtDNA)
Time Frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts
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mtDNA levels will be assesed from day 5 or day 6 blastocysts
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
preimplantation chromosomal aneuploidy
Time Frame: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts
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aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts
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Collaborators and Investigators
Investigators
- Principal Investigator: Jack L Crain, MD, Reproductive Endocrinology Associates of Charlotte
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REACh-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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