How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome

Launched by UNIVERSITY OF TORONTO · Apr 7, 2009

Keywords

ClinConnect Summary

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 subjec...

Gender

FEMALE

Eligibility 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).