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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01048385
Recruitment Status : Terminated (A new study had shown that polar body biopsies might negatively effect the implantation potential of the embryo.)
First Posted : January 13, 2010
Last Update Posted : September 9, 2014
Ferring Pharmaceuticals
Information provided by (Responsible Party):
Robert Casper, University of Toronto

Brief Summary:
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 or disease Intervention/treatment Phase
Aneuploidy Pregnancy Miscarriage Dietary Supplement: Coenzyme Q10 concomitant treatment Dietary Supplement: Placebo Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Concomitant Co Enzyme Q10 Use on Pregnancy Outcome of IVF
Study Start Date : December 2009
Actual Primary Completion Date : December 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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).

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

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

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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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

Responsible Party: Robert Casper, Prof., University of Toronto Identifier: NCT01048385     History of Changes
Other Study ID Numbers: CoQ10-IVF
First Posted: January 13, 2010    Key Record Dates
Last Update Posted: September 9, 2014
Last Verified: September 2014

Keywords provided by Robert Casper, 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