Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

Study Overview
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Brief Summary
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The goal of the investigators research is to explore energy production of the ovarian follicle in older reproductive age women at the time of oocyte retrieval.

Official Title
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Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age

Conditions
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Ovarian Function at Advanced Reproductive Age

Intervention / Treatment
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* Dietary Supplement: Coenzyme Q10 concomitant treatment
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 38-43 years at the time of enrollment Diagnosis of primary infertility Exclusion Criteria: Body mass index (BMI) > 30 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, or fertility medications. 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.

Ages Eligible for Study
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Minimum Age: 38 Years
Maximum Age: 43 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Coenzyme Q10 concomitant treatment<br>Coenzyme Q10 concomitant treatment to fertility drugs as part of an IVF treatment Dose: 600 mg by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the CoEnzyme Q10 if conceives or when the study is completed. Other name: Ubiquinone | Dietary Supplement: Coenzyme Q10 concomitant treatment<br> <br> |
| Placebo Comparator: Placebo<br>1 capsule by mouth daily beginning 3 months prior to IVF cycle. Patient will stop taking the placebo when she conceives or when the study is completed. | Dietary Supplement: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| level of ATP production |  | 2 years | 
| Steriodogenesis associated enzymatic activity |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian Response |  | 2 years | 
| Embryo quality |  | 2 years | 
| cumulative pregnancy rate per retrieval |  | 2 years | 
| cumulative live birth rate per retrieval |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Advanced Reproductive Age, poor ovarian response, Mitochondrial dysfunction, Mitochondrial nutrients, Coenzyme Q10, Electron transfer chain