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The Effect of Co Enzyme Q10 Together With Fertility Drugs on Pregnancy Outcome of in Vitro Fertilization (CoQ10-IVF)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University of Toronto.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Ferring Pharmaceuticals
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT01048385
First received: January 11, 2010
Last updated: January 12, 2010
Last verified: January 2010
History of Changes
  Purpose

The goal of our research is to increase live birth rates in infertile women and to reduce the incidence of aneuploidy leading to miscarriage and trisomies. We hypothesize that an age related mitochondrial dysfunction reduces the availability of energy in the oocyte and contributes to abnormal segregation of chromosomes during the meiotic division leading to oocyte aneuploidy. Based on preliminary evidence we have obtained in aged mice, we propose that dietary supplementation with Co enzyme Q10 in older women will improve mitochondrial function in the oocytes, leading to a decrease in chromosomal non-disjunction and resulting in embryos with a normal chromosomal complement. Our primary outcome measure will be determination of oocyte chromosome number by multiplex PCR based assay of polar bodies biopsied at the time of IVF. Outcomes of this proposal will enable us to address the mechanisms of ovarian aging and may explain etiology of decreased fertility in older patients. In addition, our work will add to the feasibility of single embryo transfer, thereby avoiding multiple pregnancies and their associated cost to the health care system and to society.


Condition Intervention
Aneuploidy
Pregnancy
Miscarriage
 Dietary Supplement: Coenzyme Q10 concomitant treatment
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome of IVF

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Number and percentage of euploid eggs per retrieval [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ovarian response [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Embryo quality [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cumulative pregnancy rate/retrieval [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Cumulative live birth rate/retrieval [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • CoQ10 activity in saliva and follicular fluid by arNOX assay [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 54
Study Start Date: December 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoQ10
This group will be treated concomitantly with Coenzyme Q10
 Dietary Supplement: Coenzyme Q10 concomitant treatment
Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment
Other Name: Many different brands
Placebo Comparator: Control
Treated with capsules containing the vehicle.
 Dietary Supplement: Placebo
Treated with capsules containing the vehicle (Sesame oil).
Other Name: Placebo

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  Eligibility

Ages Eligible for Study:   35 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 35-43 years at the time of enrollment
  • Diagnosis of primary infertility

Exclusion Criteria:

  • Body mass index (BMI) > 38 kg/m2
  • Early follicular phase (day 2-4) serum FSH level > 20 mIU/ml.
  • Abnormal uterine cavity as evidenced by sonohysterogram or hysterosalpingography
  • Any current use of systemic steroid medication or any infertility treatment within 3 months of study enrollment.
  • Any contraindication to being pregnant and carrying a pregnancy to term.
  • Contraindication for the use of CoQ10, Superfact, Puregon, hCG, Estrace and Progesterone suppositories.
  • Any ovarian or abdominal abnormality that may interfere with adequate TVS evaluation.
  • Absence of one or two ovaries
  • Clinically relevant systemic disease (e.g., Insulin-dependent diabetes, adrenal dysfunction, organic intracranial lesion, polycystic ovarian syndrome, 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.
  • Ejaculated sperm is not sufficient for ICSI
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
  • Abnormal COH screening blood done for both partners, including: prolactin, thyroid stimulating hormone, HIV serology, Hepatitis B and C serology, Rubella, group and screen and syphilis serology prior to participation in study.
  • Unwillingness to give written informed consent. Previous entry into this study or simultaneous participation in another clinical trial.
  • The concurrent use of any of the following drugs:
  • Daunorubicin, Doxorubicin, Blood Pressure Medications, Warfarin, Timolol, atorvastatin, cerivastatin, lovastatin, pravastatin, simvastatin gemfibrozil, tricyclic antidepressant medications (including amitriptyline, amoxapine, clomipramine, desipramine, doxepin, imipramine, nortriptyline, protriptyline, and trimipramine) multivitamins or any vitamin supplementation except Folic acid.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01048385

Contacts
Contact: Yaakov H Bentov, Dr. 416-972-0110 bentov@lunenfeld.ca
Contact: Robert F CAsper, Dr. 416-972-0777 RFCasper@aol.com

Locations
Canada, Ontario
The Toronto Center for Advanced Reproductive Technology Recruiting
Toronto, Ontario, Canada, M5S 2X9
Contact: Yaakov H Bentov, Dr.     416-972-0110     bentov@lunenfeld.ca    
Contact: Lynda Gotlieb, RN     416-972-0110     lyndag@tcartonline.com    
Sub-Investigator: Yaakov H Bentov, MD            
Sub-Investigator: Navid Esfandiari, PHD            
Principal Investigator: Robert F Casper, M.D            
Sponsors and Collaborators
University of Toronto
Ferring Pharmaceuticals
Investigators
Principal Investigator: Robert F Casper, Dr. University of Toronto
  More Information

Publications:

Responsible Party: Dr. R.F. Casper, The Toronto Center for Advanced Reproductive Technology, The Samuel Lunenfeld Research Institute, University of Toronto.
ClinicalTrials.gov Identifier: NCT01048385     History of Changes
Other Study ID Numbers: CoQ10-IVF
Study First Received: January 11, 2010
Last Updated: January 12, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Toronto:
Mitochondrial dysfunction
Mitochondrial nutrients
Aneuploidy
 Meiotic Spindle
Coenzyme Q10
Electron transfer chain

Additional relevant MeSH terms:
Abortion, Spontaneous
Aneuploidy
Pregnancy Complications
Chromosome Aberrations
Pathologic Processes
Fertility Agents
Coenzyme Q10
Ubiquinone
 Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Micronutrients
Growth Substances
Vitamins

ClinicalTrials.gov processed this record on May 22, 2013