CoQ10 Treatment to Improve Fertility in Elderly Patients

February 28, 2017 updated by: Hadassah Medical Organization

THE EFFECT OF COQ10 SUPPLEMENTATION ON FOLLICULAR CELLS' BIOLOGY/PROPERTIES IN ELDERLY IVF PATIENTS

Delaying first childbirth is a progressive trend in the developed societies. Several theories tried to explain the reproductive aging, in purpose to hasten it. One of the theories include mitochondrial dysfunction with aging. In this study we will investigate the potential of treating elderly IVF patients with CoQ10, a mitochondrial stimulator, to improve follicle cells' properties.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

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Detailed Description

Over the past 4 decades, because of cultural and social changes, women in the developed world have significantly delayed childbirth. It is well known that fertility decreases with age and that live birth rates in women over the age of 35 are significantly lower both naturally and with assisted reproduction compared to those in women under the age of 35. The decline in live birth rate reflects an increase in oocyte aneuploidy that leads to reduced embryo quality as well as an increased incidence of miscarriages and birth defects, most prominently Down's syndrome (trisomy 21). There is evidence that older infertility patients have abnormal oocyte mitochondrial activity and reduced production of ATP. The meiotic spindle, crucial for normal chromosome segregation, may not be formed properly in the absence of appropriate ATP levels. Altered spindles may result in aneuploid embryos, which implant poorly or not at all.

Coenzyme Q10 (CoQ10) is a vitamin-like antioxidant, essential for proper function of mitochondrial respiratory chain. It has been shown that there is a decrease level of CoQ10 in several tissues with aging (like muscle). We suggest that one possible explanation for altered oocyte mitochondrial function may be diminished CoQ10 substrate availability or utilization as a function of aging. The oocytes, and in fact the pre-granulosa cells which give rise to the granulosa (GC) and cumulus cells (CC), are unique in the body since there is no cell division for many years. Therefore, in older women, the oocytes and GCs in primordial follicles will have been exposed to low levels of radical oxygen species produced by mitochondrial respiration over decades, resulting in possible cumulative damage to mitochondria and DNA. Decreased availability of CoQ10 would contribute to reduced antioxidant activity and decreased ATP production by the mitochondria in the oocyte. In addition, compromised mitochondrial function in GCs can effect steroid hormone production, as steroidogenesis is initiated in the inner mitochondrial membrane. Thus, a vicious circle is created by which decreased CoQ10 bioavailability with advanced age could adversely affect meiosis and further developmental competence of gametes.

In our mice model, we demonstrated mitochondrial dysfunction in oocytes from aged dams. Of importance, we found that many of these mitochondrial abnormalities could be partially or completely corrected by maternal supplementation with CoQ10, translated into significant increase in litter size of old -treated females. We could demonstrate also "normalization" of viability and function of CC (that "nourish" oocyte) by CoQ10 supplementation. The aim of the proposed project is to investigate CoQ10 levels and CC function in women with aging and the potential of CoQ10 treatment to improve follicular function, and as a result, improve oocyte quality. If intra-follicular CoQ10 levels are shown to decrease with maternal aging, nutritional supplementation with CoQ10 can become the future "folic acid" for improving reproductive outcomes in older women and not just those with infertility issues.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel, 91200
        • Recruiting
        • Hadassah Medical Organization
        • Contact:
          • Assaf Ben-Meir, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 18-45 years old patients undergoing IVF/ICSI

Exclusion Criteria:

  • BMI>35
  • already treated with CoQ10
  • HCV carriers
  • had experimental treatment in the last 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Old-CoQ10
Dietary supplement: Co-enzyme Q10
600mg for 3 months
NO_INTERVENTION: Old
NO_INTERVENTION: Young
Young less than 33 years old participants

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Follicular fluid CoQ10 levels
Time Frame: Change in CoQ10 levels before and after 90 days of treatment
Change in CoQ10 levels before and after 90 days of treatment
cumulus cells function
Time Frame: Change in cumulus cells function before and after 90 days of treatment
Change in cumulus cells function before and after 90 days of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2017

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2013

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 28, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CoQ10follicle

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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