Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(A new study had shown that polar body biopsies might negatively effect the implantation potential of the embryo.)
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Robert Casper, University of Toronto Identifier:
First received: January 11, 2010
Last updated: September 5, 2014
Last verified: September 2014
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
Dietary Supplement: Coenzyme Q10 concomitant treatment
Dietary Supplement: Placebo

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

Resource links provided by NLM:

Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Number and percentage of euploid eggs per retrieval [ Time Frame: 1 year ]

Secondary Outcome Measures:
  • Ovarian response [ Time Frame: 2 years ]
  • Embryo quality [ Time Frame: 2 years ]
  • Cumulative pregnancy rate/retrieval [ Time Frame: 2 years ]
  • Cumulative live birth rate/retrieval [ Time Frame: 2 years ]
  • CoQ10 activity in saliva and follicular fluid by arNOX assay [ Time Frame: 2 years ]

Enrollment: 34
Study Start Date: December 2009
Study Completion Date: December 2012
Primary Completion Date: December 2012 (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).

  Show Detailed Description


Ages Eligible for Study:   35 Years to 43 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01048385

Canada, Ontario
The Toronto Center for Advanced Reproductive Technology
Toronto, Ontario, Canada, M5S 2X9
Sponsors and Collaborators
University of Toronto
Ferring Pharmaceuticals
Principal Investigator: Robert F Casper, Dr. University of Toronto
  More Information

Responsible Party: Robert Casper, Prof., University of Toronto Identifier: NCT01048385     History of Changes
Other Study ID Numbers: CoQ10-IVF
Study First Received: January 11, 2010
Last Updated: September 5, 2014

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

Additional relevant MeSH terms:
Abortion, Spontaneous
Pregnancy Complications
Chromosome Aberrations
Pathologic Processes
Coenzyme Q10
Fertility Agents
Growth Substances
Physiological Effects of Drugs
Reproductive Control Agents processed this record on April 24, 2017