Clinical trial NCT01659788: Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
Official title: Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ovarian Function at Advanced Reproductive Age
Keywords: Advanced Reproductive Age
poor ovarian response
Mitochondrial dysfunction
Mitochondrial nutrients
Coenzyme Q10
Electron transfer chain
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2012-08-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 38
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: level of ATP production
timeFrame: 2 years
measure: Steriodogenesis associated enzymatic activity
timeFrame: 2 years
Secondary outcomes:
measure: Ovarian Response
timeFrame: 2 years
measure: Embryo quality
timeFrame: 2 years
measure: cumulative pregnancy rate per retrieval
timeFrame: 2 years
measure: cumulative live birth rate per retrieval
timeFrame: 2 years
Other outcomes:
measure: Co Enzyme Q10 levels in maternal serum by HPLC
timeFrame: 2 years
Locations:
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization
Study officials:
affiliation: Hadassah Medical Organization
name: Ronit Kochman, MD
role: PRINCIPAL_INVESTIGATOR
References: