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

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

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
    


Study Type

Interventional


Primary Outcome

Embryo mitochondrial DNA (mtDNA)

Secondary Outcome

 preimplantation chromosomal aneuploidy

Condition

Mitochondrial DNA

Intervention

CoQ10

Study Arms / Comparison Groups

 sugar pill
Description:  Group 2 will receive a placebo of CoQ10

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Dietary Supplement

Estimated Enrollment

21

Start Date

April 2014

Completion Date

May 2018

Primary Completion Date

May 2018

Eligibility 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
      

Gender

Female

Ages

36 Years - 42 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Jack L Crain, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02119117

Organization ID

REACh-002


Responsible Party

Sponsor

Study Sponsor

Reproductive Endocrinology Associates of Charlotte


Study Sponsor

Jack L Crain, MD, Principal Investigator, Reproductive Endocrinology Associates of Charlotte


Verification Date

May 2018