NCT01659788Unknown不适用
Co Enzyme Q10 Improves IVF Outcome in With Advanced Reproductive Age
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- level of ATP production
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 38 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 38-43 years at the time of enrollment
- •Diagnosis of primary infertility
排除标准
- •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.
研究组 & 干预措施
Coenzyme Q10 concomitant treatment
Experimental
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
干预措施: Coenzyme Q10 concomitant treatment (Dietary Supplement)
Placebo
Placebo Comparator
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.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
level of ATP production
时间窗: 2 years
Steriodogenesis associated enzymatic activity
时间窗: 2 years
次要结局
- Ovarian Response(2 years)
- Embryo quality(2 years)
- cumulative pregnancy rate per retrieval(2 years)
- cumulative live birth rate per retrieval(2 years)
研究者
研究点 (1)
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