NCT02010164

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2016

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2013

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 12, 2013

Completed
3 years until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

March 1, 2017

Status Verified

February 1, 2017

Enrollment Period

1 year

First QC Date

November 26, 2013

Last Update Submit

February 28, 2017

Conditions

Reproductive Physiological Phenomena

Keywords

Reproductive agingMitochondria

Outcome Measures

Primary Outcomes (2)

  • Follicular fluid CoQ10 levels

    Change in CoQ10 levels before and after 90 days of treatment

  • cumulus cells function

    Change in cumulus cells function before and after 90 days of treatment

Study Arms (3)

Old-CoQ10

EXPERIMENTAL
Dietary Supplement: Co-enzyme Q10

Old

NO INTERVENTION

Young

NO INTERVENTION

Young less than 33 years old participants

Interventions

Co-enzyme Q10DIETARY_SUPPLEMENT

600mg for 3 months

Old-CoQ10

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • years old patients undergoing IVF/ICSI

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah Medical Organization

Jerusalem, Israel, 91200, Israel

RECRUITING

MeSH Terms

Interventions

coenzyme Q10

Central Study Contacts

Assaf Ben-Meir, MD

CONTACT

972-2-6776425assaf.benmeir@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 26, 2013

First Posted

December 12, 2013

Study Start

December 1, 2016

Primary Completion

December 1, 2017

Study Completion

March 1, 2018

Last Updated

March 1, 2017

Record last verified: 2017-02

Locations

IL(1)