Ovarian Function at Advanced Reproductive Age
Conditions
Keywords
Advanced Reproductive Age, poor ovarian response, Mitochondrial dysfunction, Mitochondrial nutrients, Coenzyme Q10, Electron transfer chain
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTCoenzyme Q10 concomitant treatment
DIETARY_SUPPLEMENTPlacebo
Sponsors
Hadassah Medical Organization
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
38 Years to 43 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Steriodogenesis associated enzymatic activity | 2 years |
| level of ATP production | 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Embryo quality | 2 years |
| cumulative live birth rate per retrieval | 2 years |
| cumulative pregnancy rate per retrieval | 2 years |
| Ovarian Response | 2 years |
Other
| Measure | Time frame |
|---|---|
| Co Enzyme Q10 levels in maternal serum by HPLC | 2 years |
Countries
Israel
Contacts
Primary ContactRonit Kochman, MD
Outcome results
None listed