NCT00878124

Brief Summary

As women age the ovarian response and pregnancy rate are reduced while the rate of chromosomal abnormalities in the embryos is increased. Oocyte maturation, accurate chromosomal segregation as well as early embryo development and implantation are dependent on the supply of large amounts of energy, which unlike other cells can only arise from the mitochondria. With age the mitochondria becomes less efficient due to damage to its unique DNA, resulting in decreased energy production. The proposed study will examine the effect of the combination of a dietary supplement, Co enzyme Q10 on pregnancy rate and response of the ovaries to a medication that stimulates follicle growth. The investigators hypothesize that the improved energetic state of the oocyte would result in a more accurate chromosomal separation, increased embryo quality and pregnancy rate.

Trial Health

35
At Risk

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
terminated

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

April 7, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 8, 2009

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

First QC Date

April 7, 2009

Last Update Submit

January 11, 2010

Conditions

Poor Ovarian Response

Keywords

Poor ovarian responseChromosomal aberrationspoor pregnancy outcomeLate maternal age

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Every cycle

Secondary Outcomes (3)

  • Peak estradiol level

    Every cycle

  • The number of follicles > 14 mm on day of hCG

    Every cycle

  • Number of days of stimulation/units of Menopur needed

    Every cycle

Study Arms (2)

CoQ10

EXPERIMENTAL

Coenzyme Q10 co-treatment

Dietary Supplement: Coenzyme Q10 co treatment

Placebo control

PLACEBO COMPARATOR

Placebo Co-treatment

Other: Placebo Caps

Interventions

Coenzyme Q10 co treatmentDIETARY_SUPPLEMENT

CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study.

Also known as: Ubiquinone.
CoQ10
Placebo CapsOTHER

3 caps twice a day continuously until pregnant or at the end of the study.

Placebo control

Eligibility Criteria

Age38 Years - 43 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Each patient must meet the following criteria:
  • Age 38-43 years at the time of enrollment
  • Diagnosis of primary infertility

You may not qualify if:

  • Patients must NOT have any of the following:
  • Body mass index (BMI) \> 38 kg/m2
  • Early follicular phase (day 2-4) serum FSH level \> 20 mIU/ml.
  • Abnormal uterine cavity and /or tubal blockage as evidenced by sonohysterogram or hysterosalpingography
  • Any current use of systemic steroid medication within 3 months of study enrollment.
  • Any contraindication to being pregnant and carrying a pregnancy to term.
  • Contraindication for the use of CoQ10, Menopur, hCG, and Prometrium.
  • Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
  • Absence of one ovary
  • Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, hyperprolactinemia, or hypothalamic tumor) or serious illness (Neoplasia).
  • History (within past 12 months) or current abuse of alcohol or drugs.
  • Administration of any investigational drugs within three months prior to study enrollment.
  • Any medical condition that may interfere with the absorption, distribution, metabolism or excretion of the study drugs, gastrointestinal diseases, mal absorption syndromes and liver dysfunction
  • Unexplained gynecological bleeding.
  • Abnormal sperm quality or semen sample inadequate for IUI preparation (TMC \> 1x106 post wash)
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

LifeQuest Centre for Reproductive Medicine

Toronto, Ontario, M5G 2K4, Canada

Location

Toronto center for advanced reprodutive technology

Toronto, Ontario, M5S 2X9, Canada

Location

MeSH Terms

Conditions

Chromosome Aberrations

Interventions

Ubiquinone

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Study Officials

  • Robert F Casper, Prof

    University of Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2009

First Posted

April 8, 2009

Study Start

June 1, 2009

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

CA(2)