Mitochondrial DNANCT02119117
Aneuploidy Rates in Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
A study testing CoQ10 in people with Mitochondrial DNA and Aneuploidy, run by Reproductive Endocrinology Associates of Charlotte at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 36 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Mitochondrial DNA, Aneuploidy
- What is being tested?
- CoQ10
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- BMI >39
- Active smoker
- Blood serum baseline level of CoQ10 ≥2.20 µg/mL
- Prior use of CoQ10
- Type II diabetes mellitus
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read more
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.
Read the detailed description
Brief Summary
- Conditions
- Mitochondrial DNA, Aneuploidy
- Being tested
- CoQ10, Placebo
- Keywords
- mtDNA, aneuploidy, IVF, blastocyst, COQ10
- Medical subject headings
- Aneuploidy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoQ10Dietary supplement
This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF
PlaceboDietary supplement
This is a placebo which will be administered daily to the patient for 3 months prior to IVF.
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Group 2 will receive a placebo of CoQ10 Receives: 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). Receives: Dietary Supplement: CoQ10 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo mitochondrial DNA (mtDNA)
Measured: mtDNA levels will be assesed from day 5 or day 6 blastocysts
Secondary outcomes (1)
preimplantation chromosomal aneuploidy
Measured: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitochondrial DNAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Reproductive Endocrinology Associates of Charlotte
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jack L Crain, MD, Principal investigator, Reproductive Endocrinology Associates of Charlotte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02119117
- Sponsor's protocol ID
- REACh-002
- Status last verified
- May 2018
- First submitted
- 14 Apr 2014
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blastocyst Aneuploidy Rates From Advanced Maternal Age Patients Supplemented With Coenzyme Q10 (CoQ10) Versus Those That Are Not: a Pilot Study
- ClinicalTrials.gov ID
- NCT02119117
- Acronym / sponsor ID
- REACh-002
- Conditions
- Mitochondrial DNA, Aneuploidy
- Keywords
- mtDNA, aneuploidy, IVF, blastocyst, COQ10
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Reproductive Endocrinology Associates of CharlotteUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Dietary Supplement: PlaceboGroup 2 will receive a placebo of CoQ10 |
| CoQ10 | Experimental | Dietary Supplement: CoQ10Patients 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). |
Who may qualify
- Ages
- 36 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- BMI >39
- Active smoker
- Blood serum baseline level of CoQ10 ≥2.20 µg/mL
- Prior use of CoQ10
- Type II diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoQ10This is a dietary supplement which will be administered daily to the patient for 3 months prior to IVF | Dietary supplement | CoQ10 |
| PlaceboThis is a placebo which will be administered daily to the patient for 3 months prior to IVF. | Dietary supplement | sugar pill |
Primary outcome
Embryo mitochondrial DNA (mtDNA)
Time frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts
1 secondary outcome
preimplantation chromosomal aneuploidy
Time frame: aneuploidy rates will be measured utilizing SNP array from day 5 and day 6 blastocysts
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack L Crain, MD principal investigator
Reproductive Endocrinology Associates of Charlotte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CoQ10 in people with Mitochondrial DNA and Aneuploidy, run by Reproductive Endocrinology Associates of Charlotte at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo mitochondrial DNA (mtDNA) (time frame: mtDNA levels will be assesed from day 5 or day 6 blastocysts). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.