Evaluation of FabLife's Personalised Support Program Effectiveness in Sperm Quality Improvement in Men Suffering From Hypofertility
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 75
- 试验地点
- 4
- 主要终点
- Sperm DNA fragmentation
研究概览
简要总结
FabLife is an interventional, prospective, multicentre, controlled study undertaken in metropolitan France.
The main objective is to evaluate the effect of FabLife personalised program over a period of 15 weeks on the improvement of spermatic DNA fragmentation in subfertile men compared to general dietary recommendations.
详细描述
More than 15 % of couples couldn't get pregnant after at least a year of unprotected intercourse.
The FabLife personalised program aims to improve sperm quality including sperm DNA fragmentation in subfertile men through:
- A personalized dietary program based on patient's phenotype and genotype
- A daily dietary supplement, developed in the context of male infertility
A total of 75 patients will be recruited:
- 46 patients will benefit from the program,
- 23 patients will form the control group.
- 6 patients will not answer to all the criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All male volunteers aged 18 to 45 years belonging to a couple reporting an involuntary infertility greater than 12 months
- •Conventional spermatic parameters compatible with spontaneous pregnancy
- •Sperm Count> 5M / ml and
- •Progressive sperm mobility> 20%
- •Negative spermoculture
- •Fragmentation of sperm DNA> 20%
- •Patient able to understand dietary recommendations given in French, in writing and orally
- •Social insured patient receiving benefits from the French Social Security health branch
- •Patient with a mobile phone (iOS or Android) with internet access
排除标准
- •Patient diagnosed with severe oligospermia (<5 million spz / ejaculate)
- •Patient with BMI> 35 or <18.5
- •Patient with known and treated diabetes
- •Patient with known and treated lipid disorders
- •Patient with known and treated cardiovascular diseases
- •Patients with known and treated hypertension
- •Patients with known and treated dysthyroidism
- •Patients with known symptomatic varicocele
- •Patient with known inflammatory bowel diseases
- •Patient with renal failure diagnosed
- •Patient presenting a viral risk (HIV / Hepatitis B and C / ...) requiring support in a dedicated circuit
- •Patient unable to give informed consent
- •Minors and protected adults, vulnerable people
- •Patient participating in another clinical research study
研究组 & 干预措施
FabLife group
Fablife personnalised support and telephone follow-up with a dietician.
干预措施: FabLife (Device)
Control group
General dietary recommendations.
结局指标
主要结局
Sperm DNA fragmentation
时间窗: 15 weeks
Difference in sperm DNA fragmentation from baseline to post-treatment
次要结局
- Sperm motility(15 weeks)
- Sperm concentration(15 weeks)
- Semen volume(15 weeks)
- Sperm morphology(15 weeks)
- Total sperm count(15 weeks)
- Semen quality(15 weeks)