Effect of Oral Administration of Astaxanthin on Semen Quality, Fertilization and Embryo Development in Assisted Reproduction Techniques Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- semen quality
研究概览
简要总结
The purpose of the study is to determine whether administration of dietary supplement of astaxanthin with vitamin E improves the quality of sperm, fertilization and embryo development in Assisted Reproduction Techniques (ART) procedures.
详细描述
In the study male patients diagnosed with oligoasthenozoospermia - with an abnormal sperm concentration and motility, irrespective of the morphology of spermatozoa - treated with their female partner with assisted reproduction techniques (ISCI) will be included. In the double blind study male patients will be given astaxanthin with vitamin E (study group, 40 patients) or placebo (control group, 40 patients) for three months prior to ART. In the study and the control group the quality of sperm (spermiogram), DNA fragmentation and mitochondrial membrane potential of semen before and after the dietary supplementation will be evaluated. In the ART procedure (ICSI) the fertilization rate, the quality of embryos, pregnancy rates and miscarriages rates in 1st trimester will be compared between the study and control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
no other masking
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •oligoasthenozoospermia with of without teratozoospermia by WHO criteria from the year 2010
- •fresh semen
- •female partner younger than 38 years
- •idiopathic or tubal infertility in female partners
- •at least 4 oocytes retrieved in previous ovarian punction in ART cycle, if previously performed
- •1st, 2nd or 3rd cycle of ART
排除标准
- •genetic indication for ART procedure
- •donated semen
- •polycystic ovary syndrome in female partner
- •dietary supplementation intake of antioxidants (selenium, zink, vitamin E, vitamin C, vitamin A) in male participant in the last three months
- •smoking in male participant >20 cigarettes per day
研究组 & 干预措施
astaxanthin with vitamin E
The participants in the study group will be given perorally four tablets of 4 mg astaxanthin with 10 mg vitamin E (Astasan, Sensilab, Slovenia) daily, taken in single daily dose. The total daily dose will be 16 mg astaxanthin with 40 mg vitamin E. The product will be taken for three months continuously.
干预措施: astaxanthin with vitamin E (Dietary Supplement)
placebo
The participants in the control group will be given perorally four tablets of placebo daily taken in single daily dose. The placebo tablets are of the same size and colour as the study tablets and were produced by manufacturer of Astasan, Sensilab, Slovenia. The placebo will be taken for three months continuously.
干预措施: Placebo (Other)
结局指标
主要结局
semen quality
时间窗: three months
In semen quality the spermiogram, DNA fragmentation and mitochondrial membrane potential before and after the intervention will be evaluated. The DNA fragmentation will be evaluated by terminal deoxynucleotidyl transferase-mediated deoxyuridine triphosphate (dUTP)-biotin nick end labeling (TUNEL) method, and mitochondrial membrane potential with carbocyanine fluorochrome DiOC6.
次要结局
- pregnancy rates and miscarriage rates in 1st trimester after ART(nine months)
- follicle stimulating hormone (FSH)(three months)
- fertilization and embryo development in Assisted Reproduction Techniques (ART)(six months)
研究者
Bojana Pinter
Assoc. Prof., MD, PhD, Spec in Ob/Gyn, MS (Econ)
University Medical Centre Ljubljana