How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome (CoQ10)

This study has been terminated.
(Very low recruitment rate)
Sponsor:
Collaborators:
Toronto Centre for Advanced Reproductive Technology
Ferring Pharmaceuticals
Information provided by:
University of Toronto
ClinicalTrials.gov Identifier:
NCT00878124
First received: April 7, 2009
Last updated: January 11, 2010
Last verified: January 2010
  Purpose

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.


Condition Intervention
Poor Ovarian Response
Dietary Supplement: Coenzyme Q10 co treatment
Other: Placebo Caps

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

Resource links provided by NLM:


Further study details as provided by University of Toronto:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: Every cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Peak estradiol level [ Time Frame: Every cycle ] [ Designated as safety issue: No ]
  • The number of follicles > 14 mm on day of hCG [ Time Frame: Every cycle ] [ Designated as safety issue: No ]
  • Number of days of stimulation/units of Menopur needed [ Time Frame: Every cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2009
Arms Assigned Interventions
Experimental: CoQ10
Coenzyme Q10 co-treatment
Dietary Supplement: Coenzyme Q10 co treatment
CoenzymeQ10 300mg twice a day continuously. Ceased when patient conceives or at the end of the study.
Other Name: Ubiquinone.
Placebo Comparator: Placebo control
Placebo Co-treatment
Other: Placebo Caps
3 caps twice a day continuously until pregnant or at the end of the study.

Detailed Description:

The study will be organized on an outpatient basis at the Toronto Centre for Advanced Reproductive Technology (TCART) and at the Lifequest Centre for Reproductive Medicine. The study will involve 100 women aged 38-43 years.

In the first cycle, study participants will be randomly assigned to either placebo or COQ10 capsules, (AOR - Advanced Orthomolecular Research Inc. 19 St NE Calgary, Alberta, NHPD registration codes 135307 and 113519, respectively). Study participants will take 600 mg of CoQ10 orally or identical placebo capsules for up to 5 cycles if pregnancy does not occur. All subjects will commence controlled ovarian stimulation (COH) using highly purified human menopausal gonadotropins (Menopur; Ferring Inc., North York,Ontario Canada). The starting dosage of Menopur will range from 75IU to 250 IU daily S.C. will be determined by the physician and will begin on the third day of menses, and will continue until the day prior to human chorionic gonadotropin (hCG) administration. The dosage will not be changed and must be maintained for the duration of the study. Menopur will continue daily until follicular development is considered adequate. (at least 1 follicle is >17 mm, and the E2 level is acceptable for the number of follicles present). The patient will receive an injection of hCG 250 mcg (Ovidrel, EMD Serono,Oakville, Ontario, Canada ), SC for the final stage of follicular maturation. Insemination will be by intrauterine insemination (IUI). Luteal support will consist of progesterone suppositiories 200mg (Kingsway Pharmacy,Toronto, Ontario Canada) vaginally per day starting on the day of IUI and will continue for 2 weeks until the serum beta hCG result. At the end of each cycle serum beta hCG will be drawn and if women are pregnant CoQ10/ placebo will be discontinued. If pregnant, luteal support will continue until 10 weeks gestation. If the patient is not pregnant she will have a cycle off COH but may attempt to conceive naturally. In the third cycle, COH using the same dose of Menopur as in the first cycle will be performed with IUI as in cycle one. If not pregnant, another cycle off treatment will be followed by the fifth cycle in which COH and IUI is performed..

The study endpoints will be:

  1. Primary outcome measure will be pregnancy rate.
  2. Secondary outcome measures will include:

    • Peak estradiol level
    • The number of follicles > 14 mm on day of hCG
    • Number of days of stimulation / units of Menopur needed
  Eligibility

Ages Eligible for Study:   38 Years to 43 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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)
  • Patient not able to communicate adequately with the investigators and to comply with the requirements of the entire study.
  • Abnormal COH screening bloods for either partner, including: HIV serology, Hepatitis B and C serology, Rubella, and syphilis serology prior to participation in study.
  • Unwillingness to give written informed consent.
  • The concurrent use of any of the following drugs:
  • CoQ10: 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).
  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 ClinicalTrials.gov identifier: NCT00878124

Locations
Canada, Ontario
Toronto center for advanced reprodutive technology
Toronto, Ontario, Canada, M5S 2X9
LifeQuest Centre for Reproductive Medicine
Toronto, Ontario, Canada, M5G 2K4
Sponsors and Collaborators
University of Toronto
Toronto Centre for Advanced Reproductive Technology
Ferring Pharmaceuticals
Investigators
Principal Investigator: Robert F Casper, Prof University of Toronto
  More Information

No publications provided

Responsible Party: Dr. Yaakov Bentov, University of Toronto
ClinicalTrials.gov Identifier: NCT00878124     History of Changes
Other Study ID Numbers: CoQ10 - 08-0205-A
Study First Received: April 7, 2009
Last Updated: January 11, 2010
Health Authority: Canada: Institutional Review Board

Keywords provided by University of Toronto:
Poor ovarian response
Chromosomal aberrations
poor pregnancy outcome
Late maternal age

Additional relevant MeSH terms:
Coenzyme Q10
Ubiquinone
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Vitamins

ClinicalTrials.gov processed this record on July 26, 2014