Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
Primary Purpose
Mitochondrial DNA, Aneuploidy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CoQ10
Placebo
Sponsored by
About this trial
This is an interventional basic science trial for Mitochondrial DNA focused on measuring mtDNA, aneuploidy, IVF, blastocyst, COQ10
Eligibility Criteria
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
Sites / Locations
- REACh
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
sugar pill
CoQ10
Arm Description
Group 2 will receive a placebo of 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).
Outcomes
Primary Outcome Measures
Embryo mitochondrial DNA (mtDNA)
Secondary Outcome Measures
preimplantation chromosomal aneuploidy
Full Information
NCT ID
NCT02119117
First Posted
April 14, 2014
Last Updated
May 3, 2018
Sponsor
Reproductive Endocrinology Associates of Charlotte
1. Study Identification
Unique Protocol Identification Number
NCT02119117
Brief Title
Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
Official Title
Blastocyst Aneuploidy Rates From Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
April 2014 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Reproductive Endocrinology Associates of Charlotte
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Brief Summary
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitochondrial DNA, Aneuploidy
Keywords
mtDNA, aneuploidy, IVF, blastocyst, COQ10
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
sugar pill
Arm Type
Placebo Comparator
Arm Description
Group 2 will receive a placebo of CoQ10
Arm Title
CoQ10
Arm Type
Experimental
Arm Description
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).
Intervention Type
Dietary Supplement
Intervention Name(s)
CoQ10
Intervention Description
This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
This is a placebo which will be administered daily to the patient for 3 months prior to IVF.
Primary Outcome Measure Information:
Title
Embryo mitochondrial DNA (mtDNA)
Time Frame
mtDNA levels will be assesed from day 5 or day 6 blastocysts
Secondary Outcome Measure Information:
Title
preimplantation chromosomal aneuploidy
Time Frame
aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jack L Crain, MD
Organizational Affiliation
Reproductive Endocrinology Associates of Charlotte
Official's Role
Principal Investigator
Facility Information:
Facility Name
REACh
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
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