Status:
TERMINATED
How Dose Coenzyme Q10 Supplementation During Infertility Treatment Effects Pregnancy Outcome
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Toronto Centre for Advanced Reproductive Technology
Ferring Pharmaceuticals
Conditions:
Poor Ovarian Response
Eligibility:
FEMALE
38-43 years
Phase:
NA
Brief Summary
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...
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 ...
Eligibility Criteria
Inclusion
- Each patient must meet the following criteria:
- Age 38-43 years at the time of enrollment
- Diagnosis of primary infertility
Exclusion
- 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).
Key Trial Info
Start Date :
June 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00878124
Start Date
June 1 2009
Last Update
January 12 2010
Active Locations (2)
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1
LifeQuest Centre for Reproductive Medicine
Toronto, Ontario, Canada, M5G 2K4
2
Toronto center for advanced reprodutive technology
Toronto, Ontario, Canada, M5S 2X9