The Effect of Co Enzyme Q10 Together With Fertility Drugs on Pregnancy Outcome of in Vitro Fertilization

Launched by UNIVERSITY OF TORONTO · Jan 12, 2010

Keywords

ClinConnect Summary

The objective of this study is to evaluate the efficacy of CoQ10 administration with respect to its effect on the rate of aneuploidy of oocytes and cumulative live birth rate.

Study Design This is a prospective randomized placebo controlled study. Study participants will undergo up to 3 cycles as part of this protocol. All clinical assessments will be conducted at the participating infertility clinics.

The study will be organized on an outpatient basis at the Toronto Centre for Advanced Reproductive Technology (TCART). The study will involve 54 women aged 35-43 years undergoing IVF treatm...

Gender

FEMALE

Eligibility 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.